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
1081–1104 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 24, 2020
Custodiol HTK Solution
K192408 · KDL
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 233d
Cleared Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K192017 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 270d
Cleared Apr 23, 2020
Duo-Flow Side x Side Double Lumen Catheter
K192807 · MPB
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 205d
Cleared Apr 23, 2020
RocaTub Ureteral Catheter
K192183 · EYB
Promepal Sam
Gastroenterology & Urology · 255d
Cleared Apr 21, 2020
Lariat, Hot/Cold Snare
K200745 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 21, 2020
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way...
K192034 · EZL
Pathway, LLC
Gastroenterology & Urology · 266d
Cleared Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
K200257 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared Apr 16, 2020
EON Portable RO Water Purification System
K200670 · FIP
Mar Cor Purification, Inc.
Gastroenterology & Urology · 34d
Cleared Apr 15, 2020
G-EYE System
K192588 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 209d
Cleared Apr 14, 2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
K200388 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 56d
Cleared Apr 08, 2020
Standard Bougie
K191885 · KNT
Standard Bariatrics
Gastroenterology & Urology · 268d
Cleared Apr 06, 2020
Irrigation Tubing with CO2 or Air
K193250 · OCX
Keymed (Medical and Industrial...
Gastroenterology & Urology · 133d
Cleared Apr 02, 2020
Ambu aScope 4 Cysto
K193095 · FAJ
Ambu A/S
Gastroenterology & Urology · 147d
Cleared Mar 31, 2020
Tablo Hemodialysis System
K200741 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 31, 2020
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K200556 · EZL
H R Pharmaceuticals, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 27, 2020
Single Use Grasping Forceps
K191900 · OCZ
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 255d
Cleared Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 156d
Cleared Mar 13, 2020
PrisMax System Version 3
K193482 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 87d
Cleared Mar 13, 2020
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System...
K193325 · KNT
Prosys International, Ltd.
Gastroenterology & Urology · 102d
Cleared Mar 12, 2020
AMT Suture Delivery System
K193612 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 05, 2020
Instinct Plus Endoscopic Clipping Device
K192697 · PKL
Cook Endoscopy
Gastroenterology & Urology · 161d
Cleared Mar 05, 2020
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis...
K190527 · MSD
C. R. Bard
Gastroenterology & Urology · 367d
Cleared Feb 27, 2020
Fusion Quattro Extraction Balloon
K200247 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 27, 2020
Disposable Sclerotherapy Needle
K190032 · FBK
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 416d