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
6121–6144 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 05, 1993
GUIDE-TECH ENCAPSULATED GUIDEWIRE
K926039 · KNY
Cape Tech Medical Products
Gastroenterology & Urology · 247d
Cleared Aug 05, 1993
ADVANCE MODEL UDS-ADV
K931574 · EXQ
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 128d
Cleared Jul 30, 1993
PULSE GUARD ELECTRODE
K925396 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 277d
Cleared Jul 29, 1993
GASTROPORT II
K924308 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 337d
Cleared Jul 23, 1993
NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
K930474 · FHO
Ranfac, Corp.
Gastroenterology & Urology · 176d
Cleared Jul 23, 1993
URETERAL STENT
K930733 · FAD
Surgitek
Gastroenterology & Urology · 162d
Cleared Jul 23, 1993
URINARY DRAINAGE BAG CADDY
K931727 · FAQ
Neotech Products, Inc.
Gastroenterology & Urology · 142d
Cleared Jul 23, 1993
RESECTOSCOPE SHEATH
K931995 · FJL
Olympus Corp.
Gastroenterology & Urology · 91d
Cleared Jul 21, 1993
NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
K925161 · KNY
North American Sterilization &...
Gastroenterology & Urology · 281d
Cleared Jul 20, 1993
URO-PRO 2000
K922476 · FAP
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 420d
Cleared Jul 20, 1993
FST COUNCIL TIP FOLEY CATHETER
K922776 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 406d
Cleared Jul 16, 1993
URETERAL CATHETER
K930483 · EYB
Surgitek
Gastroenterology & Urology · 168d
Cleared Jul 13, 1993
4 SURE TM FEEDING TUBES
K921853 · KNT
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 452d
Cleared Jul 13, 1993
URESIL BILLIARY CATHETER
K923096 · FGE
Uresil Corp.
Gastroenterology & Urology · 383d
Cleared Jul 09, 1993
ONIK-COHEN ACCESS SET
K930608 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 154d
Cleared Jul 08, 1993
UROLOGICAL CATHETER & ACCESSORIES
K930882 · FAD
Applied Medical Resources
Gastroenterology & Urology · 139d
Cleared Jul 06, 1993
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · GCT
Medical Devices, Inc.
Gastroenterology & Urology · 280d
Cleared Jul 02, 1993
SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
K915258 · FIP
Aqua-Med Systems, Inc.
Gastroenterology & Urology · 591d
Cleared Jul 02, 1993
VASOVASOSTOMY SET
K921546 · KOA
Cook Urological, Inc.
Gastroenterology & Urology · 457d
Cleared Jul 02, 1993
LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
K924134 · GCS
Leisegang Medical, Inc.
Gastroenterology & Urology · 318d
Cleared Jul 01, 1993
VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS
K914162 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 653d
Cleared Jul 01, 1993
VAS-CATH DUALATOR(TM) VESSEL DILATOR
K914210 · FKA
Vas-Cath, Inc.
Gastroenterology & Urology · 651d
Cleared Jul 01, 1993
CONE CATH
K931156 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 01, 1993
GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
K931340 · GCS
Baxter Healthcare Corp
Gastroenterology & Urology · 107d