Company ยท US
Surgitek
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1995. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAD | Stent, Ureteral | 9 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 |
| FGO | Dislodger, Stone, Flexible | 2 |
| LCJ | Tissue Expander And Accessories | 2 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 |
| FAE | Prosthesis, Penile | 1 |
| FBO | Cystourethroscope | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
| FMF | Syringe, Piston | 1 |
| FZW | Expander, Surgical, Skin Graft | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| LIL | Monitor, Penile Tumescence | 1 |
| LKY | Device, External Penile Rigidity | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 1995 | K946296 | QUADRA-COIL URETERAL STENT Surgitek | FAD |
| Feb 7, 1995 | K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM Surgitek | FEN |
| Aug 5, 1994 | K943491 | RIGHT ANGLE UROLOGIC LASER FIBER Surgitek | GEX |
| May 24, 1994 | K941952 | SURGITEK INFUSER Surgitek | FAD |
| Jan 11, 1994 | K933261 | GRASPING FORCEPS Surgitek | FGO |
| Jan 11, 1994 | K933260 | HELICAL STONE/FLATWIRE STONE BASKETS Surgitek | FFL |
| Jul 23, 1993 | K930733 | URETERAL STENT Surgitek | FAD |
| Jul 16, 1993 | K930483 | URETERAL CATHETER Surgitek | EYB |
| Mar 5, 1993 | K926344 | HYDROPHILIC COATED GUIDEWIRE Surgitek | KNY |
| Sep 17, 1992 | K920451 | ENDOTEK ULTRA SYSTEM Surgitek | FAP |
| Aug 19, 1992 | K922542 | GRASPING FORCEPS Surgitek | FGO |
| Mar 5, 1991 | K904797 | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) Surgitek | FBO |
| Mar 5, 1991 | K904793 | SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) Surgitek | FGB |
| Dec 28, 1990 | K905015 | SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE Surgitek | LKY |
| Sep 5, 1990 | K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER Surgitek | FZW |
| Jan 17, 1990 | K894495 | SURGITEK(R) EXTERNAL FILL PORT Surgitek | LCJ |
| Jun 2, 1989 | K891339 | IRRI-FLO IRRIGATION DELIVERY SYSTEM Surgitek | OCX |
| Apr 14, 1988 | K880660 | SURGITEK SUPER DOUBLE J URETERAL STENT KIT Surgitek | FAD |
| Apr 13, 1988 | K875333 | SURGITEK NPT MONITOR Surgitek | LIL |
| Sep 16, 1987 | K872353 | SURGITEK INFUSION STENT SYSTEM* Surgitek | FAD |
| Apr 29, 1987 | K870518 | SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT Surgitek | FMF |
| Dec 18, 1986 | K863492 | METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. Surgitek | FAD |
| Apr 2, 1984 | K834347 | FLEXI-FLATE PENILE IMPLANT Surgitek | FAE |
| Apr 2, 1984 | K833782 | SURGITEK ALL SILICONE INFECTION DOUBJ Surgitek | FAD |
| Mar 12, 1984 | K840464 | TISSUE EXPANDER Surgitek | LCJ |
| Feb 4, 1984 | K840059 | SILITEK URINARY DIVERSION STENT Surgitek | FAD |
| Dec 27, 1983 | K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF Surgitek | BTS |
| Nov 28, 1983 | K833628 | LUMEN-4 URODYNAMIC CATHETER Surgitek | FAP |
| Oct 14, 1983 | K832915 | URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN Surgitek | FAD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||