Degania Silicone, Inc.
Mount Pleasant, WI, US
DEGANIA SILICONE, INC. appears in FDA device records in Mount Pleasant, WI. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 43 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Degania Silicone, Inc. between 1988 and 2026. The busiest year on record is 2014, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1992 | 1 |
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 2007 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 4 |
| 2016 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | PIF | Substantially Equivalent | |
| K233591 | Stylus | KNT | Substantially Equivalent | |
| K152246 | Aquarius Stoma Measuring Device | KNT | Substantially Equivalent | |
| K143378 | AQUARIUS Gastrostomy Replacement Tube | KNT | Substantially Equivalent | |
| K141753 | AQUARIUS NASAL FEEDING TUBE | PIF | Substantially Equivalent | |
| K141631 | AQUARIUS EXTENSION FEEDING SET | KNT | Unknown | |
| K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE | KNT | Unknown | |
| K131020 | TEMPERATURE SENSOR CATHETER | EZL | Substantially Equivalent | |
| K122030 | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON | KNT | Substantially Equivalent | |
| K103371 | COUDE/ OR TIEMANN | EZL | Substantially Equivalent | |
| K070124 | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 | KNT | Substantially Equivalent | |
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | EZL | Substantially Equivalent | |
| K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | Substantially Equivalent | |
| K971482 | DEGANIA SILICONE SIL-K | MDA | Substantially Equivalent | |
| K964547 | DEGANIA SILICONE INDENTI LOOPS | DXC | Substantially Equivalent | |
| K953864 | SILCLEAR TUBING (MODIFICATION) | FPK | Substantially Equivalent | |
| K943992 | SILCLEAR TUBING | FPK | Substantially Equivalent | |
| K914701 | SIL-K | MDA | Substantially Equivalent | |
| K875092 | DEGANIA SILICONE TOURNIQUET | GAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1225868 | 3001853045 | DEGANIA SILICONE, INC. | 1100 Commerce Dr Ste 108, Mount Pleasant, WI 53406 US | 2026 | No device listings on this registration |
| 8030107 | 7682 | DEGANIA SILICONE, LTD. | KIBBUTZ, DEGANIA BET Northern 1513000 IL | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- PRPBalloon Gastrostomy Tube Kit
- GBXCatheter, Irrigation
- EZLCatheter, Retention Type, Balloon
- EYCCatheter, Upper Urinary Tract
- KODCatheter, Urological
- GBSCatheter, Ventricular, General & Plastic Surgery
- DXCClamp, Vascular
- FAJCystoscope And Accessories, Flexible/Rigid
- KYGDevice, Irrigation, Ocular Surgery
- HDYDilator, Cervical, Hygroscopic-Laminaria
- PUIDrape, Surgical, Exempt
- MDAElastomer, Silicone, For Scar Management
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- PSHPercutaneous Replacement Gastrostomy Tube Kit
- LRWScissors, General, Surgical
- HFSShield, Nipple
- GAXTourniquet, Nonpneumatic
- FPDTube, Feeding
- KNTTubes, Gastrointestinal (And Accessories)
- FPKTubing, Fluid Delivery
Recall records
Showing 25 of 43| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0809-2020 | Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage. | Temperature deviation did not meet release specifications | Class II | Terminated | |
| Z-2267-2019 | Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2266-2019 | Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2265-2019 | Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2264-2019 | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2263-2019 | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2262-2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2261-2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2260-2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Class II | Terminated | |
| Z-2785-2018 | Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2784-2018 | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2783-2018 | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2782-2018 | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2781-2018 | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2780-2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2779-2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2778-2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2777-2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2776-2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2775-2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2774-2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2773-2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2772-2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2771-2018 | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated | |
| Z-2770-2018 | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain