FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
4777–4800 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 06, 1998
QUICK-CUT AUTOMATIC BIOPSY SYSTEM
K980479 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 89d
Cleared May 06, 1998
CHARGER (ED)
K980567 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 82d
Cleared May 06, 1998
XTEND
K980752 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 75d
Cleared May 01, 1998
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 59d
Cleared Apr 28, 1998
NTECH CYSTOSCOPES
K980592 · FAJ
N-Tech Endoscopy, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 27, 1998
MANAN VS ACCESS NEEDLE/SET
K980372 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 22, 1998
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Apr 22, 1998
MANAN MANTA CATHETER FIXATION DISK
K981229 · KNY
Medical Device Technologies, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 22, 1998
MANAN MALECOT BASKET DRAINAGE CATHETER
K981258 · FEW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 21, 1998
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS...
K980465 · FDT
Olympus America, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 16, 1998
STERICHEK PERACETIC ACID REAGENT STRIPS
K980164 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 16, 1998
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
K980305 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 79d
Cleared Apr 10, 1998
AMT DECOMPRESSION TUBES
K980145 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 85d
Cleared Apr 08, 1998
URESIL NEPHRO-URETERAL STENT
K980889 · LJE
Uresil Corp.
Gastroenterology & Urology · 30d
Cleared Apr 07, 1998
NEVA SYSTEM
K980627 · LIL
Urometrics, Inc.
Gastroenterology & Urology · 48d
Cleared Apr 03, 1998
WALLSTENT ENTERAL ENDOPROSTHESIS
K980113 · MUM
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 80d
Cleared Mar 31, 1998
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE...
K974493 · FDS
Fiegert-Endotech Medizintechnik GmbH
Gastroenterology & Urology · 123d
Cleared Mar 31, 1998
UROMED PATCH
K974600 · MNG
Uromed Corp.
Gastroenterology & Urology · 112d
Cleared Mar 31, 1998
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
K980919 · EZL
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 20d
Cleared Mar 30, 1998
JMS APHERESIS NEEDLE
K974902 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 27, 1998
TRIANGLE SLING
K980482 · OTN
Influence, Inc.
Gastroenterology & Urology · 46d
Cleared Mar 23, 1998
VYGON NEO-SUMP
K974806 · KNT
Vygon Corp.
Gastroenterology & Urology · 90d
Cleared Mar 20, 1998
CRE(TM) BALLOON DILATATION CATHETER
K974788 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Mar 20, 1998
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798 · LIF
Environmental Test Systems, Inc.
Gastroenterology & Urology · 88d