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
601–624 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 28, 2023
Pathfinder Endoscope Overtube with Balloon Device
K230801 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 127d
Cleared Jul 27, 2023
Teleflex Rusch SoftSimplastic Foley Catheters
K212077 · EZL
Teleflexmedical, Inc.
Gastroenterology & Urology · 755d
Cleared Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K231878 · FGB
STERIS Corporation
Gastroenterology & Urology · 29d
Cleared Jul 25, 2023
ME-APDS™
K223473 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 250d
Cleared Jul 21, 2023
EndoflipTM 300 System
K231861 · FFX
Covidien, LLC
Gastroenterology & Urology · 28d
Cleared Jul 19, 2023
RenaPure Endotoxin Retentive Filter
K231410 · FIP
Evoqua Water Technologies, LLC
Gastroenterology & Urology · 65d
Cleared Jul 10, 2023
EnteraLoc Flow
K223683 · PIF
Vonco Products
Gastroenterology & Urology · 214d
Cleared Jul 07, 2023
ANDORATE® Valve Kit
K230932 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 95d
Cleared Jun 30, 2023
ClearTip
K231267 · FCG
Finemedix Co., Ltd.
Gastroenterology & Urology · 59d
Cleared Jun 30, 2023
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K230991 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 85d
Cleared Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K231549 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jun 29, 2023
Flume Catheter
K231101 · EZL
Flume Catheter Company, Ltd.
Gastroenterology & Urology · 72d
Cleared Jun 22, 2023
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use...
K223741 · FBN
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 190d
Cleared Jun 21, 2023
Habib EndoHPB
K231533 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Jun 21, 2023
Tablo® Hemodialysis System
K223248 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 243d
Cleared Jun 16, 2023
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines...
K230514 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 112d
Cleared Jun 16, 2023
NAJA Gastrointestinal Catheter
K223890 · FGD
Chess Medical, Inc.
Gastroenterology & Urology · 171d
Cleared Jun 15, 2023
WallFlex™ Biliary RX Stent System
K223469 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 210d
Cleared Jun 14, 2023
ClearumTM HS
K231406 · KDI
Bellco Srl
Gastroenterology & Urology · 30d
Cleared Jun 14, 2023
Niti-S Duodenal Stent
K223067 · MUM
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 264d
Not Cleared Jun 09, 2023
Eroxon
DEN220078 · QWW
Futura Medical Developments Limited
Gastroenterology & Urology · 231d
Cleared Jun 02, 2023
i3 ONE (203100-S)
K222727 · NHV
I3 Membrane GmbH
Gastroenterology & Urology · 267d
Cleared May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
K213992 · FJK
Fresenius Medical Care Renal...
Gastroenterology & Urology · 526d
Cleared May 30, 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 60d