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
1225–1248 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 31, 2019
U Deliver Bolink ENFit Enteral Feeding Sets
K190310 · PIF
U Deliver Medical, LLC
Gastroenterology & Urology · 108d
Cleared May 31, 2019
Pristine Hemodialysis Catheter
K182443 · MSD
Pristine Access Technologies , Ltd.
Gastroenterology & Urology · 266d
Cleared May 30, 2019
Arc Endocuff Glide AEG110 & AEG120
K191067 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 38d
Cleared May 29, 2019
Swiss LithoClast Trilogy
K191124 · FFK
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 30d
Cleared May 29, 2019
Entuit PEG, Entuit PEGJ
K183336 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 177d
Cleared May 29, 2019
Segmented Esophageal Stent System
K182910 · ESW
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 224d
Cleared May 29, 2019
Peel-Away Introducer
K182403 · FED
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 77d
Cleared May 24, 2019
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
K181979 · KOD
Teleflexmedical, Inc.
Gastroenterology & Urology · 303d
Cleared May 23, 2019
ERBEFLO 2 Disposable Tubing System
K190469 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 86d
Cleared May 17, 2019
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part...
K183035 · LJE
Cook Incorporated
Gastroenterology & Urology · 197d
Cleared May 15, 2019
Flexible Overtube
K182520 · FED
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 244d
Cleared May 15, 2019
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife...
K182408 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 253d
Cleared May 14, 2019
BAROnova Insufflation System, BAROnova Accessory Kit
K190985 · FCX
Baronova, Inc.
Gastroenterology & Urology · 29d
Cleared May 08, 2019
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic...
K183461 · GBM
Teleflexmedical, Inc.
Gastroenterology & Urology · 145d
Cleared May 07, 2019
Scope ProTech
K191011 · OCU
Meditech Endoscopy, Ltd.
Gastroenterology & Urology · 21d
Cleared May 07, 2019
FUJIFILM Endoscope Model EC-760S-V/L
K190649 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 55d
Cleared May 04, 2019
Medline Quick-Clear Wand
K183577 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 134d
Cleared May 03, 2019
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible...
K183188 · FGB
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 165d
Cleared May 01, 2019
Brush Biopsy Set
K182231 · FDX
Cook Incorporated
Gastroenterology & Urology · 257d
Cleared Apr 30, 2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
K190114 · KNT
Convatec Limited
Gastroenterology & Urology · 96d
Cleared Apr 30, 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip...
K183540 · PNR
Neomed, Inc.
Gastroenterology & Urology · 131d
Cleared Apr 29, 2019
Magnetic Surgical System
K190006 · PNL
Levita Magnetics International Corp
Gastroenterology & Urology · 117d
Cleared Apr 25, 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787 · PIF
Cedic S.R.L.
Gastroenterology & Urology · 294d