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
9313–9336 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 14, 1980
COBE HEMOFLO BLOOD TUBING SETS
K801211 · FJK
Cobe Laboratories, Inc.
Gastroenterology & Urology · 55d
Cleared Jul 08, 1980
HEMORRHOIDAL LIGATION INSTR. SYSTEM
K801352 · FHN
Depuy, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354 · KOC
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355 · KOC
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356 · KOC
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jun 30, 1980
GF120H DIALYZER
K801045 · FJI
Gambro, Inc.
Gastroenterology & Urology · 56d
Cleared Jun 26, 1980
HESSLER COLON THERAPY DEVICE
K800565 · KPL
Hessler Mfg. Co.
Gastroenterology & Urology · 105d
Cleared Jun 20, 1980
LINEBERGER EXTERNAL MALE CATHETER
K800890 · KNX
Lineberger External Catheter Co.
Gastroenterology & Urology · 63d
Cleared Jun 17, 1980
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
K800822 · FAP
Kli
Gastroenterology & Urology · 64d
Cleared Jun 09, 1980
ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS
K801144 · FHT
Ethox Corp.
Gastroenterology & Urology · 27d
Cleared Jun 09, 1980
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K801223 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 17d
Cleared May 30, 1980
MMG DISPOSABLE URINARY LEG BAG
K800694 · KNX
Medical Marketing Group
Gastroenterology & Urology · 64d
Cleared May 30, 1980
JOHNLOZ ENDOSCOPY HANDLE
K800915 · KNS
Endoscopic Surgical Accessories, Inc.
Gastroenterology & Urology · 39d
Cleared May 30, 1980
TUBE FEEDING CONTAINER 1500 ML DISPOSE.
K800955 · KNT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 37d
Cleared May 30, 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K801016 · FJK
Gambro, Inc.
Gastroenterology & Urology · 31d
Cleared May 20, 1980
MOD. DM-356 IPS INTERFACE MODULE
K800771 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 43d
Cleared May 14, 1980
MICRO-COIL 100 COIL DIALYZER
K800723 · FHS
Erika, Inc.
Gastroenterology & Urology · 43d
Cleared May 14, 1980
MOD. DM-357 BICARBONATE RETROFIT KIT
K800772 · FKR
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 37d
Cleared May 14, 1980
GYNECOLOGICAL CYSTO/URETHROSCOPE
K800913 · FGC
Kli
Gastroenterology & Urology · 23d
Cleared May 14, 1980
LARGE VOLUME ENEMA CONTAINER DISPOSABLE
K800959 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
1500 ML DISPOSABLE ENEMA CONTAINER(1110)
K800960 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
ENEMA CONTAINER DISP. FOR EMEMA ADMIN.
K800961 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 08, 1980
QUIK-TEMP
K800666 · KPP
Liquid Crystal Products, Inc.
Gastroenterology & Urology · 43d
Cleared May 08, 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · FJI
Cordis Corp.
Gastroenterology & Urology · 38d