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
4561–4584 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · MND
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Jun 11, 1999
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE,...
K991178 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 65d
Cleared Jun 10, 1999
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT...
K980438 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 491d
Cleared Jun 09, 1999
FUJI CATHETER, MODEL CTH001
K983867 · KNW
Windy Hill Technology, Inc.
Gastroenterology & Urology · 219d
Cleared Jun 09, 1999
MTP UROPUMP DISPOSABLE TUBING SET
K990909 · LJH
Mtp Medical Technical Promotion GmbH
Gastroenterology & Urology · 83d
Cleared Jun 09, 1999
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/...
K991003 · FKY
Dayspring Medical, Inc.
Gastroenterology & Urology · 76d
Cleared Jun 08, 1999
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN...
K983511 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 244d
Cleared Jun 08, 1999
DISTENDER SERIES II BAROSTAT
K991288 · FFX
G & J Electronics, Inc.
Gastroenterology & Urology · 55d
Cleared Jun 04, 1999
GASTRIC AND RECTAL CATHETERS
K973844 · FFX
G & J Electronics, Inc.
Gastroenterology & Urology · 604d
Cleared Jun 04, 1999
STRYKER INFRAVISION ESOPHAGEAL KIT
K983220 · FAT
Stryker Endoscopy
Gastroenterology & Urology · 263d
Cleared Jun 04, 1999
AUTO SUTURE ABBI SYSTEM
K983296 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 256d
Cleared Jun 01, 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 78d
Cleared May 26, 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 30d
Cleared May 20, 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 66d
Cleared May 19, 1999
GALLINI ATRA-CUT NEEDLE
K990645 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 82d
Cleared May 18, 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 187d
Cleared May 18, 1999
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
K990509 · EZL
Implemed, Inc.
Gastroenterology & Urology · 89d
Cleared May 17, 1999
MANOMETRIC ASSEMBLIES
K983665 · KLA
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 210d
Cleared May 17, 1999
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS...
K983720 · MSE
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 208d
Cleared May 17, 1999
GALLINI BYCUT NEEDLE
K990716 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 74d
Cleared May 17, 1999
JACKSON ESOPHAGEAL DILATOR
K990935 · KNQ
Pilling Weck Surgical
Gastroenterology & Urology · 59d
Cleared May 13, 1999
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
K990515 · KNW
International Medical Systems
Gastroenterology & Urology · 84d
Cleared May 12, 1999
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
K990441 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared May 07, 1999
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND...
K990507 · KPO
Althin Biopharm, Inc.
Gastroenterology & Urology · 78d