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
409–432 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
K241598 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Jul 01, 2024
StarFormer
K234061 · KPI
Fotona D.O.O.
Gastroenterology & Urology · 192d
Cleared Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
K240164 · FIB
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 158d
Cleared Jun 27, 2024
Pathfinder® CR System
K240853 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Jun 24, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
K233630 · FGB
Ambu A/S
Gastroenterology & Urology · 224d
Cleared Jun 21, 2024
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
K240663 · FAJ
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 105d
Cleared Jun 21, 2024
GERDX-System
K233240 · ODE
G-Surg GmbH
Gastroenterology & Urology · 267d
Cleared Jun 19, 2024
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
K232997 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 271d
Cleared Jun 14, 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
K233079 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 262d
Cleared Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 258d
Cleared Jun 13, 2024
AquaBplus
K232953 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared Jun 12, 2024
PLASMA EDGE System
K240504 · FAS
Lamidey Noury Medical
Gastroenterology & Urology · 112d
Cleared Jun 10, 2024
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB,...
K240283 · FAJ
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 130d
Cleared Jun 10, 2024
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection]...
K232911 · FGB
Karl Storz Endovision, Inc.
Gastroenterology & Urology · 265d
Cleared Jun 07, 2024
Disposable Hemostatic Clips
K232969 · PKL
Ningbo Xinwell Medical Technology...
Gastroenterology & Urology · 260d
Cleared Jun 07, 2024
Uro-G HD Flexible Cystoscope
K232837 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 267d
Cleared Jun 06, 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 06, 2024
Wellead® Latex Foley Catheter
K233094 · MJC
Well Lead Medical (Hainan) Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Jun 03, 2024
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K240617 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 31, 2024
multiFlux 1000 (F00012408)
K240394 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 113d
Cleared May 31, 2024
Stylus
K233591 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 205d
Cleared May 17, 2024
Yoni.Fit Bladder Support
K232525 · HHW
Watkins-Conti Products, Inc.
Gastroenterology & Urology · 270d
Cleared May 16, 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 30d
Cleared May 10, 2024
Ureterorenoscope System
K240374 · FGB
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 93d