Surgitek - FDA 510(k) Cleared Devices

Cleared Mar 06, 1995

QUADRA-COIL URETERAL STENT

K946296 · FAD

Gastroenterology & Urology · 69d

Cleared Feb 07, 1995

OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM

K944391 · FEN

Gastroenterology & Urology · 151d

Cleared May 24, 1994

SURGITEK INFUSER

K941952 · FAD

Gastroenterology & Urology · 32d

Cleared Jan 11, 1994

HELICAL STONE/FLATWIRE STONE BASKETS

K933260 · FFL

Gastroenterology & Urology · 189d

Cleared Jan 11, 1994

GRASPING FORCEPS

K933261 · FGO

Gastroenterology & Urology · 189d

Cleared Jul 23, 1993

URETERAL STENT

K930733 · FAD

Gastroenterology & Urology · 162d

Cleared Jul 16, 1993

URETERAL CATHETER

K930483 · EYB

Gastroenterology & Urology · 168d

Cleared Mar 05, 1993

HYDROPHILIC COATED GUIDEWIRE

K926344 · KNY

Gastroenterology & Urology · 78d

Cleared Sep 17, 1992

ENDOTEK ULTRA SYSTEM

K920451 · FAP

Gastroenterology & Urology · 226d

Cleared Aug 19, 1992

GRASPING FORCEPS

K922542 · FGO

Gastroenterology & Urology · 82d

Cleared Mar 05, 1991

SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)

K904793 · FGB

Gastroenterology & Urology · 133d

Cleared Mar 05, 1991

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)

K904797 · FBO

Gastroenterology & Urology · 133d

Cleared Dec 28, 1990

SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE

K905015 · LKY

Gastroenterology & Urology · 51d

Cleared Jun 02, 1989

IRRI-FLO IRRIGATION DELIVERY SYSTEM

K891339 · OCX

Gastroenterology & Urology · 84d

Cleared Apr 14, 1988

SURGITEK SUPER DOUBLE J URETERAL STENT KIT

K880660 · FAD

Gastroenterology & Urology · 57d

Cleared Apr 13, 1988

SURGITEK NPT MONITOR

K875333 · LIL

Gastroenterology & Urology · 105d

Cleared Sep 16, 1987

SURGITEK INFUSION STENT SYSTEM*

K872353 · FAD

Gastroenterology & Urology · 90d

Cleared Dec 18, 1986

METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.

K863492 · FAD

Gastroenterology & Urology · 100d

Cleared Apr 02, 1984

SURGITEK ALL SILICONE INFECTION DOUBJ

K833782 · FAD

Gastroenterology & Urology · 157d

Cleared Apr 02, 1984

FLEXI-FLATE PENILE IMPLANT

K834347 · FAE

Gastroenterology & Urology · 111d

Cleared Feb 04, 1984

SILITEK URINARY DIVERSION STENT

K840059 · FAD

Gastroenterology & Urology · 26d

Cleared Nov 28, 1983

LUMEN-4 URODYNAMIC CATHETER

K833628 · FAP

Gastroenterology & Urology · 45d

Cleared Oct 14, 1983

URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN

K832915 · FAD

Gastroenterology & Urology · 46d