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
5041–5064 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 20, 1997
VISTA SINGLE CHIP VIDEO CAMERA
K971373 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 36d
Cleared May 20, 1997
CLARUS MODEL 5197 SIGHTLITE
K971455 · FTI
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared May 19, 1997
FREEDOM TRAVELLER
K964825 · MLW
Impact Case Technologies, Inc.
Gastroenterology & Urology · 168d
Cleared May 16, 1997
MANAN V.S. ACCESS NEEDLE/SET
K963767 · FGE
Manan Medical Products, Inc.
Gastroenterology & Urology · 239d
Cleared May 16, 1997
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
K970716 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 78d
Cleared May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
K970799 · LIF
Alexander Mfg. Co.
Gastroenterology & Urology · 71d
Cleared May 12, 1997
MEDISYSTEMS TRANDUCER PROTECTOR
K970536 · FIB
Medisystems Corp.
Gastroenterology & Urology · 89d
Cleared May 09, 1997
T-RX RETRIEVAL FORCEPS
K970982 · OCZ
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 52d
Cleared May 08, 1997
VAPOR-TECH SLED ELECTRODE
K970717 · FAS
Northgate Technologies, Inc.
Gastroenterology & Urology · 70d
Cleared May 07, 1997
ANGLED TIP POLYPECTOMY SNARE
K970945 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared May 05, 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · OCV
Olympus America, Inc.
Gastroenterology & Urology · 486d
Cleared May 05, 1997
O'REGAN LIGATOR
K963166 · FHN
Patrick J. O'Regan
Gastroenterology & Urology · 264d
Cleared May 05, 1997
FIEGERT ENDOTECH CYSTOSCOPE
K970892 · FAJ
Fiegert, Inc.
Gastroenterology & Urology · 55d
Cleared May 05, 1997
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
K971498 · EZB
Applied Medical Resources
Gastroenterology & Urology · 10d
Cleared May 02, 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
K963782 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 224d
Cleared Apr 30, 1997
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
K955592 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 510d
Cleared Apr 28, 1997
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K964119 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · KOB
The Kendal Co.
Gastroenterology & Urology · 37d
Cleared Apr 22, 1997
RESECTOSCOPE CUTTING LOOP ELECTRODE
K964365 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 172d
Cleared Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · KPI
Empi
Gastroenterology & Urology · 85d
Cleared Apr 22, 1997
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
K970764 · OCX
Comeg Endoscopy
Gastroenterology & Urology · 50d
Cleared Apr 22, 1997
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
K970966 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 18, 1997
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
K955487 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 504d
Cleared Apr 17, 1997
VS-100 VIDEO SIGMOIDOSCOPE
K970382 · FAM
Welch Allyn, Inc.
Gastroenterology & Urology · 73d