Surgitek
Mchenry, IL, US
Surgitek appears in FDA device records in Mchenry, IL. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Surgitek between 1983 and 1995. The busiest year on record is 1984, with 4. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 3 |
| 1984 | 4 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 4 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K946296 | QUADRA-COIL URETERAL STENT | FAD | Substantially Equivalent | |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | FEN | Substantially Equivalent | |
| K943491 | RIGHT ANGLE UROLOGIC LASER FIBER | GEX | Substantially Equivalent | |
| K941952 | SURGITEK INFUSER | FAD | Substantially Equivalent | |
| K933261 | GRASPING FORCEPS | FGO | Substantially Equivalent | |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | FFL | Substantially Equivalent | |
| K930733 | URETERAL STENT | FAD | Substantially Equivalent | |
| K930483 | URETERAL CATHETER | EYB | Unknown | |
| K926344 | HYDROPHILIC COATED GUIDEWIRE | KNY | Substantially Equivalent | |
| K920451 | ENDOTEK ULTRA SYSTEM | FAP | Substantially Equivalent | |
| K922542 | GRASPING FORCEPS | FGO | Substantially Equivalent | |
| K904797 | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) | FBO | Substantially Equivalent | |
| K904793 | SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) | FGB | Substantially Equivalent | |
| K905015 | SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE | LKY | Substantially Equivalent | |
| K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER | FZW | Substantially Equivalent | |
| K894495 | SURGITEK(R) EXTERNAL FILL PORT | LCJ | Substantially Equivalent | |
| K891339 | IRRI-FLO IRRIGATION DELIVERY SYSTEM | OCX | Substantially Equivalent | |
| K880660 | SURGITEK SUPER DOUBLE J URETERAL STENT KIT | FAD | Substantially Equivalent | |
| K875333 | SURGITEK NPT MONITOR | LIL | Substantially Equivalent | |
| K872353 | SURGITEK INFUSION STENT SYSTEM* | FAD | Substantially Equivalent | |
| K870518 | SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT | FMF | Substantially Equivalent | |
| K863492 | METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. | FAD | Substantially Equivalent | |
| K834347 | FLEXI-FLATE PENILE IMPLANT | FAE | Substantially Equivalent | |
| K833782 | SURGITEK ALL SILICONE INFECTION DOUBJ | FAD | Substantially Equivalent | |
| K840464 | TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K840059 | SILITEK URINARY DIVERSION STENT | FAD | Substantially Equivalent | |
| K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | BTS | Substantially Equivalent | |
| K833628 | LUMEN-4 URODYNAMIC CATHETER | FAP | Substantially Equivalent | |
| K832915 | URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN | FAD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- EYBCatheter, Ureteral, Gastro-Urology
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- FBOCystourethroscope
- FENDevice, Cystometric, Hydraulic
- LKYDevice, External Penile Rigidity
- FFLDislodger, Stone, Basket, Ureteral, Metal
- FGODislodger, Stone, Flexible
- OCXEndoscopic Irrigation/Suction System
- FZWExpander, Surgical, Skin Graft
- LILMonitor, Penile Tumescence
- GEXPowered Laser Surgical Instrument
- FAEProsthesis, Penile
- FADStent, Ureteral
- FMFSyringe, Piston
- LCJTissue Expander And Accessories
- BTSTube, Bronchial (W/Wo Connector)
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain