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
1297–1320 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 16, 2019
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS...
K181451 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 229d
Cleared Jan 16, 2019
Dosis SAM
K180410 · MQS
Dosis, Inc.
Gastroenterology & Urology · 336d
Cleared Jan 10, 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
K183616 · MQR
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 15d
Cleared Jan 10, 2019
Signal Catheter
K182635 · EZL
Safe Medical Design
Gastroenterology & Urology · 108d
Cleared Jan 10, 2019
DIASAFEplusUS
K182367 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 132d
Cleared Jan 03, 2019
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor...
K181127 · PTE
Interscope, Inc.
Gastroenterology & Urology · 248d
Cleared Dec 26, 2018
One-Step Suprapubic Introducer
K182709 · KOB
Cook Incorporated
Gastroenterology & Urology · 90d
Cleared Dec 21, 2018
Clear-Jet Injection Catheter
K181690 · FBK
Finemedix Co., Ltd.
Gastroenterology & Urology · 178d
Not Cleared Dec 20, 2018
SEM Scanner (Model 200)
DEN170021 · QEF
Bruin Biometrics, LLC
Gastroenterology & Urology · 626d
Cleared Dec 18, 2018
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253 · GBM
Hollister Incorporated
Gastroenterology & Urology · 27d
Cleared Dec 18, 2018
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756 · FCG
Apriomed AB
Gastroenterology & Urology · 169d
Cleared Dec 14, 2018
SureClip Repositionable Hemostasis Clip
K182556 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Dec 07, 2018
FiXcision
K182664 · KOA
Agency For Medical Innovations GmbH
Gastroenterology & Urology · 73d
Cleared Dec 07, 2018
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid),...
K180679 · KPO
Global Scientific Technologies, LLC
Gastroenterology & Urology · 267d
Cleared Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer...
K180615 · LKN
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Nov 23, 2018
Greene Renal Transplant Stent Set
K180557 · FAD
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Nov 21, 2018
Roth Net Retriever Product Line
K182909 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 20, 2018
Telepack X LED
K182696 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 54d
Cleared Nov 16, 2018
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 18d
Cleared Nov 16, 2018
SmartBag (SmartPouch)
K181643 · EXB
11 Health Technologies Limited
Gastroenterology & Urology · 147d
Cleared Nov 15, 2018
SITZMARKS
K181750 · FFX
Konsyl Pharmaceuticals
Gastroenterology & Urology · 136d
Cleared Nov 15, 2018
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
K180668 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 246d
Cleared Nov 14, 2018
HPM-6000UF
K181497 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 160d