Surgitek
Medical device manufacturer in Racine, WI.
29510(k) clearances
0PMA approvals
0recalls
Device types
- FAD Stent, Ureteral 9
- FAP Cystometric Gas (Carbon-Dioxide) On… 2
- LCJ Tissue Expander And Accessories 2
- FGO Dislodger, Stone, Flexible 2
- FEN Device, Cystometric, Hydraulic 1
- GEX Powered Laser Surgical Instrument 1
- FFL Dislodger, Stone, Basket, Ureteral, Metal 1
- EYB Catheter, Ureteral, Gastro-Urology 1
- KNY Accessories, Catheter, G-U 1
- FBO Cystourethroscope 1
- FGB Ureteroscope And Accessories, Flexible/Rigid 1
- LKY Device, External Penile Rigidity 1
- FZW Expander, Surgical, Skin Graft 1
- OCX Endoscopic Irrigation/Suction System 1
- LIL Monitor, Penile Tumescence 1
- FMF Syringe, Piston 1
- FAE Prosthesis, Penile 1
- BTS Tube, Bronchial (W/Wo Connector) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K946296 | Quadra-Coil Ureteral StentFAD · Traditional | 03/06/1995SE |
| K944391 | OM-4 (Tenative) Urodynamic Measruement SystemFEN · Traditional | 02/07/1995SE |
| K943491 | Right Angle Urologic Laser FiberGEX · Traditional | 08/05/1994SE |
| K941952 | Surgitek InfuserFAD · Traditional | 05/24/1994SE |
| K933261 | Grasping ForcepsFGO · Traditional | 01/11/1994SE |
| K933260 | Helical Stone/Flatwire Stone BasketsFFL · Traditional | 01/11/1994SE |
| K930733 | Ureteral StentFAD · Traditional | 07/23/1993SE |
| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
| K926344 | Hydrophilic Coated GuidewireKNY · Traditional | 03/05/1993SE |
| K920451 | Endotek Ultra SystemFAP · Traditional | 09/17/1992SE |
| K922542 | Grasping ForcepsFGO · Traditional | 08/19/1992SE |
| K904797 | Surgitek Graduated Cystoscope (Model GC-16)FBO · Traditional | 03/05/1991SE |
| K904793 | Surgitek Graduated Ureteroscope (Model GU-8)FGB · Traditional | 03/05/1991SE |
| K905015 | Surgitek Erectek TM External Erection DeviceLKY · Traditional | 12/28/1990SE |
| K902349 | Surgitek Intra-Span Intraoperative Tissue ExpanderFZW · Traditional | 09/05/1990SE |
| K894495 | Surgitek(R) External Fill PortLCJ · Traditional | 01/17/1990SE |
| K891339 | Irri-Flo Irrigation Delivery SystemOCX · Traditional | 06/02/1989SE |
| K880660 | Surgitek Super Double J Ureteral Stent KitFAD · Traditional | 04/14/1988SE |
| K875333 | Surgitek NPT MonitorLIL · Traditional | 04/13/1988SE |
| K872353 | Surgitek Infusion Stent System*FAD · Traditional | 09/16/1987SE |
| K870518 | Surgitek Physician Dispen. Patient Self-Inject KitFMF · Traditional | 04/29/1987SE |
| K863492 | Metal Tipped Ureter. Stent & Magnetic Stent Retri.FAD · Traditional | 12/18/1986SE |
| K834347 | Flexi-Flate Penile ImplantFAE · Traditional | 04/02/1984SE |
| K833782 | Surgitek All Silicone Infection DoubjFAD · Traditional | 04/02/1984SE |
| K840464 | Tissue ExpanderLCJ · Traditional | 03/12/1984SE |
| K840059 | Silitek Urinary Diversion StentFAD · Traditional | 02/04/1984SE |
| K833297 | Bronchoscopy Tube W/Ultra LocuffBTS · Traditional | 12/27/1983SE |
| K833628 | LUMEN-4 Urodynamic CatheterFAP · Traditional | 11/28/1983SE |
| K832915 | Urethral Obstruct Primary Exchange StenFAD · Traditional | 10/14/1983SE |