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
1105–1128 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Not Cleared Feb 25, 2020
iTind System
DEN190020 · QKA
Medi-Tate , Ltd.
Gastroenterology & Urology · 329d
Cleared Feb 24, 2020
Aquadex FlexFlow System 2.0
K192756 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 147d
Cleared Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry...
K191474 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 265d
Cleared Feb 21, 2020
PatCom Single-Use Introducer
K192691 · FED
H&A Mui Enterprises, Inc.
Gastroenterology & Urology · 148d
Cleared Feb 14, 2020
CapsoCam Plus (SV-3) Capsule Endoscopy System
K192662 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 142d
Cleared Feb 07, 2020
Desara One Single Incision Sling System, 1 Pack
K191416 · PAH
Caldera Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Jan 31, 2020
Arc Enterocuff
K191330 · FDA
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 260d
Cleared Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 155d
Cleared Jan 30, 2020
EndoClot
K191254 · PLL
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Jan 29, 2020
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc,...
K191498 · LJE
Cook Incorporated
Gastroenterology & Urology · 238d
Cleared Jan 27, 2020
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K191715 · OCU
STERIS Corporation
Gastroenterology & Urology · 215d
Cleared Jan 22, 2020
HydroPearl Microspheres
K192684 · NOY
MicroVention, Inc.
Gastroenterology & Urology · 118d
Cleared Jan 22, 2020
Isopure Dry Acid Dissolution System
K191093 · KPO
Isopure, Corp.
Gastroenterology & Urology · 272d
Cleared Jan 17, 2020
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K193182 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 60d
Cleared Jan 17, 2020
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter,...
K192302 · MPB
Covidien, LLC
Gastroenterology & Urology · 147d
Cleared Jan 16, 2020
SherpaPak Lung Preservation System , SherpaPak Liver Transport System
K192869 · KDN
Pragonix Technologies
Gastroenterology & Urology · 101d
Cleared Jan 16, 2020
INNOVO
K192357 · QAJ
Atlantic Therapeutics, Ltd.
Gastroenterology & Urology · 140d
Cleared Jan 03, 2020
Endotics
K190669 · FDF
Era Endoscopy S.R.L.
Gastroenterology & Urology · 294d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 216d
Cleared Jan 02, 2020
Optilume Basic Urological Balloon Dilation Catheter
K191061 · KOE
Urotronic, Inc.
Gastroenterology & Urology · 255d
Cleared Dec 30, 2019
Disposable Valve Sets
K192258 · ODC
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 132d
Not Cleared Dec 23, 2019
Mucosal Integrity Conductivity (MI) Test System
DEN180067 · QIS
Diversatek Healthcare, Inc.
Gastroenterology & Urology · 371d
Cleared Dec 20, 2019
UroLift System (UL400)
K193269 · PEW
Neotract, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 20, 2019
Telepack +
K193235 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 25d