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
5713–5736 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 24, 1995
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
K945576 · EZN
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 71d
Cleared Jan 20, 1995
INNOVA PELVIC FLOOR STIMULATION SYSTEM
K941911 · KPI
Empi
Gastroenterology & Urology · 276d
Cleared Jan 20, 1995
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
K946238 · FCL
Symbiosis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 19, 1995
CRIT-LINE BLOOD CHAMBER WITH E-BEAM
K935958 · KOC
In-Line Diagnostics Corp.
Gastroenterology & Urology · 419d
Cleared Jan 19, 1995
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND...
K945202 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 86d
Cleared Jan 11, 1995
GUARDPORT
K921478 · KNT
Health Improvement Assoc.
Gastroenterology & Urology · 1017d
Cleared Jan 11, 1995
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
K925406 · FGE
Schneider Intl., Ltd.
Gastroenterology & Urology · 807d
Cleared Jan 11, 1995
BAXTER CA DIALYZER
K926567 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 741d
Cleared Jan 10, 1995
CAT-600 PENILE PLETHYSMOGRAPH
K936115 · LIL
Farrall Instruments, Inc.
Gastroenterology & Urology · 690d
Cleared Jan 10, 1995
CAT-400UL PENILE PLETHYSMOGRAPH
K940128 · LIL
Farrall Instruments, Inc.
Gastroenterology & Urology · 365d
Cleared Jan 09, 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · KNT
Abbott Laboratories
Gastroenterology & Urology · 972d
Cleared Jan 04, 1995
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
K945201 · ESW
Cook, Inc.
Gastroenterology & Urology · 71d
Cleared Jan 04, 1995
FOG FREE
K945732 · OCT
Tonn Chemical Co., Inc.
Gastroenterology & Urology · 42d
Cleared Dec 30, 1994
AN-10S ANDERSEN TUBE WITH STYLET
K935688 · BSS
H.W. Andersen Products, Inc.
Gastroenterology & Urology · 396d
Cleared Dec 30, 1994
ENTERAL DELIVERY SETS WITH HYDRATION PORT
K943675 · KNT
Clintec Technologies, Inc.
Gastroenterology & Urology · 157d
Cleared Dec 30, 1994
R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102
K944294 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 119d
Cleared Dec 30, 1994
R&D BATTERIES PART NOS. 5354 AND 5150
K944386 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 114d
Cleared Dec 29, 1994
ZINETICS AMC
K921682 · FFX
Zinetics Medical, Inc.
Gastroenterology & Urology · 995d
Cleared Dec 29, 1994
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 822d
Cleared Dec 29, 1994
REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION
K931595 · FIP
Osmonics, Inc.
Gastroenterology & Urology · 638d
Cleared Dec 29, 1994
INNOVA VAGINAL EMG SENSING ELECTRODE
K940091 · HIR
Empi
Gastroenterology & Urology · 356d
Cleared Dec 29, 1994
R&D PART 5518, 5306, 5315 AND 5457
K945867 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 23, 1994
TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
K934348 · BSS
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 472d
Cleared Dec 23, 1994
CHAKOFF ENDOSCOPY
K945421 · FDG
Stephen Chakoff, Inc.
Gastroenterology & Urology · 49d