Cogentix Medical, Inc.
Westborough, MA, US
COGENTIX MEDICAL, INC. appears in FDA device records in Westborough, MA. FDA records list 35 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Cogentix Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Vision-Sciences, Inc.510(k), recall
510(k) clearance history
FDA records hold 35 510(k) clearances for Cogentix Medical, Inc. between 1986 and 2026. The busiest year on record is 1996, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 5 |
| 1997 | 1 |
| 1999 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 5 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253905 | PrimeSight UltraView System | FAJ | Substantially Equivalent | |
| K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor | EOX | Substantially Equivalent | |
| K102733 | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR | EOB | Substantially Equivalent | |
| K100125 | VISION SCIENCES FLEXIBLE ENT SCOPE | EOB | Substantially Equivalent | |
| K091768 | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES | EOQ | Substantially Equivalent | |
| K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | FAJ | Substantially Equivalent | |
| K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | HIH | Substantially Equivalent | |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | EOX | Substantially Equivalent | |
| K072073 | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR | EOB | Substantially Equivalent | |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | EOX | Substantially Equivalent | |
| K053560 | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE | FAJ | Substantially Equivalent | |
| K050972 | VISION-SCIENCES ENT-3000 SCOPE | EOB | Substantially Equivalent | |
| K040984 | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE | EOB | Substantially Equivalent | |
| K040215 | VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM | FAJ | Substantially Equivalent | |
| K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | EOX | Substantially Equivalent | |
| K031790 | SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING | EOB | Substantially Equivalent | |
| K024095 | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM | EOB | Substantially Equivalent | |
| K012543 | VISION SCIENCES ENDOSHEATH SYSTEM | EOB | Substantially Equivalent | |
| K021344 | B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM | EOQ | Substantially Equivalent | |
| K990354 | ENDOSHEATH | EOB | Substantially Equivalent | |
| K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM | FAM | Substantially Equivalent | |
| K963795 | VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH | EOQ | Substantially Equivalent | |
| K964100 | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 | FAM | Substantially Equivalent | |
| K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE | FAM | Substantially Equivalent | |
| K950809 | VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES | EOB | Substantially Equivalent | |
| K961591 | DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE | EOB | Substantially Equivalent | |
| K942265 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH | EOB | Substantially Equivalent | |
| K943715 | VISION SYSTEM UPPER G.I. EXDOSCOPE | FDS | Substantially Equivalent | |
| K943895 | VISION SYSTEM COLONSCOPE | FDF | Substantially Equivalent | |
| K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH | FAM | Substantially Equivalent | |
| K933247 | PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS | EOB | Substantially Equivalent | |
| K925421 | ENDOSHEATH | EOB | Substantially Equivalent | |
| K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | FAM | Substantially Equivalent | |
| K921244 | DISPOSABLE PROTECTIVE SHEATH | EOB | Substantially Equivalent | |
| K863367 | FORMALENS 2000 | HQG | Substantially Equivalent for Some Indications |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1223490 | 1000136543 | COGENTIX MEDICAL, INC. | 135 Flanders Rd, Westborough, MA 01581 US | 2026 | |
| 2242464 | 2242464 | COGENTIX MEDICAL, INC. | 40 Ramland Rd S, ORANGEBURG, NY 10962 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EOQBronchoscope (Flexible Or Rigid)
- FWLCamera, Cine, Endoscopic, Without Audio
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FENDevice, Cystometric, Hydraulic
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- EOXEsophagoscope (Flexible Or Rigid)
- FDSGastroscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- FFSImage, Illumination, Fiberoptic, For Endoscope
- EQLLaryngostroboscope
- NTNLed Light Source
- HQGLens, Spectacle, Non-Custom (Prescription)
- EOBNasopharyngoscope (Flexible Or Rigid)
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0929-2012 | Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries. | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. | Terminated | ||
| Z-0928-2012 | Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries. | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain