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
6913–6936 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 19, 1990
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · FIL
Baxter Healthcare Corp
Gastroenterology & Urology · 44d
Cleared Apr 18, 1990
GS-4000 REDUCER SLEEVE, 11MM TO 5MM
K900955 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
GS-4100 REDUCER SLEEVE, 5MM TO 3MM
K900961 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
GS-4300 CANNULA AND TROCAR, 5.5MM
K900962 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
GS-4350 TROCAR ONLY, 5.5MM
K900963 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
CANNULA AND TROCAR, 11MM
K900964 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
GS-4550 TROCAR ONLY, 11MM
K900965 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 17, 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 16, 1990
URINARY LEG BAG
K896129 · FAQ
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 175d
Cleared Apr 16, 1990
BIOPSY FORCEP (NON-ELECTRIC)
K896147 · FCL
Portlyn Corp.
Gastroenterology & Urology · 175d
Cleared Apr 13, 1990
ENEMA KIT 'Y' DESIGN
K900847 · FCE
Custom Medical Products, Ltd.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1990
ENEMA KIT 'STRAIGHT' DESIGN
K900848 · FCE
Custom Medical Products, Ltd.
Gastroenterology & Urology · 50d
Cleared Apr 10, 1990
MOTIONSPECT
K895881 · LXW
Baltimore Therapeutic Equipment Co.
Gastroenterology & Urology · 187d
Cleared Apr 09, 1990
GUARDIAN FORCEP
K893636 · FCL
Endo-Scientific, Inc.
Gastroenterology & Urology · 332d
Cleared Apr 09, 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Mar 29, 1990
BARD/ANGIOMED STENTS
K896391 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 143d
Cleared Mar 27, 1990
L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K897181 · FPD
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 89d
Cleared Mar 26, 1990
URO TEX URINALS
K901000 · EYZ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 23, 1990
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
K895792 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 176d
Cleared Mar 23, 1990
CATHETER EXTENSION SET CAT. NO. 48-3027-9
K895992 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 161d
Cleared Mar 22, 1990
URO-BAGGIE
K895168 · KNX
Cwt Workshop
Gastroenterology & Urology · 212d
Cleared Mar 22, 1990
DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET
K895990 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 160d
Cleared Mar 22, 1990
PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6
K895991 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 160d