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
1441–1464 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 16, 2018
SOZO
K180126 · OBH
ImpediMed Limited
Gastroenterology & Urology · 90d
Cleared Apr 16, 2018
Hemoclip
K172727 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Apr 16, 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
K171603 · FAD
Cook Incorporated
Gastroenterology & Urology · 319d
Cleared Apr 12, 2018
Padlock Clip defect closure device
K180689 · PKL
STERIS Corporation
Gastroenterology & Urology · 28d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Apr 10, 2018
Eviva Stereotactic Guided Breast Biopsy System
K180233 · KNW
Hologic, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 04, 2018
leva Pelvic Floor Trainer
K180637 · HIR
Renovia, Inc.
Gastroenterology & Urology · 23d
Cleared Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
K180194 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 30, 2018
OLYMPUS URF-V2/V2R
K172246 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 247d
Cleared Mar 30, 2018
Dimesol Tubing Sets for Hemodialysis
K171952 · FJK
Dimesol, Inc.
Gastroenterology & Urology · 274d
Cleared Mar 30, 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · PNR
Amsino International, Inc.
Gastroenterology & Urology · 282d
Cleared Mar 29, 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · EZL
Poiesis Medical, LLC
Gastroenterology & Urology · 134d
Cleared Mar 29, 2018
OLYMPUS URF-P6/P6R
K172298 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 241d
Cleared Mar 28, 2018
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket,...
K171969 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Mar 26, 2018
Black Silicone Filiform Double Pigtail Stent Set
K172017 · FAD
Cook Incorporated
Gastroenterology & Urology · 266d
Cleared Mar 22, 2018
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
K173105 · ODC
Cook Incorporated
Gastroenterology & Urology · 174d
Cleared Mar 21, 2018
Captura® Disposable Hot Biopsy Forceps
K171973 · KGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 264d
Cleared Mar 20, 2018
Habib EndoHPB
K180165 · KNS
Emcision , Ltd.
Gastroenterology & Urology · 57d
Cleared Mar 20, 2018
Single Use Hemoclip
K172762 · PKL
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 188d
Cleared Mar 20, 2018
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon...
K171989 · ODD
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 260d
Cleared Mar 15, 2018
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Mar 15, 2018
Incontinence Treatment Device, Model LT2061
K171430 · KPI
Shenzhen Dongdixin Technology Co., Ltd.
Gastroenterology & Urology · 304d
Cleared Mar 13, 2018
Olympus Small Intestinal Capsule Endoscope System
K173459 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 126d
Cleared Mar 12, 2018
Corvocet Biopsy System
K180450 · KNW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 20d