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
433–456 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader...
K240276 · NEZ
Given Imaging Ltd. (D.B.A. Medtronic)
Gastroenterology & Urology · 100d
Cleared May 10, 2024
pureFLOW 402 (F00012067)
K233950 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared May 09, 2024
Tulsa Pro System (Pad-105)
K240296 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 98d
Cleared May 07, 2024
KARL STORZ Monopolar Resectoscopes with HF Cable
K232486 · FJL
Karl Storz SE & CO. KG
Gastroenterology & Urology · 265d
Cleared May 06, 2024
Solar Compact (G4-1)
K240007 · FFX
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 125d
Cleared May 06, 2024
ViSiGi LUX (5332)
K234033 · KNT
Boehringer Laboratories, LLC
Gastroenterology & Urology · 138d
Cleared May 03, 2024
Sleeved IC 2 Family
K233524 · EZD
Hollister Incorporated
Gastroenterology & Urology · 184d
Cleared May 03, 2024
Tablo® Hemodialysis System
K232776 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 235d
Cleared May 02, 2024
Revi™ System
K240037 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 118d
Cleared May 02, 2024
Dragonfly™ Pancreaticobiliary Scope
K233752 · FBN
CenterPoint Systems, LLC
Gastroenterology & Urology · 162d
Cleared May 01, 2024
DuraGraft Vascular Conduit Solution
K240925 · QEJ
Marizyme
Gastroenterology & Urology · 27d
Cleared May 01, 2024
Percutaneous Nephroscope System
K232370 · FGA
Karl Storz SE & CO. KG
Gastroenterology & Urology · 267d
Cleared Apr 29, 2024
Ultraflex Esophageal NG Stent System
K233939 · ESW
Boston Scientific
Gastroenterology & Urology · 137d
Cleared Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
K240879 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 23, 2024
Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
K234107 · KLA
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 119d
Cleared Apr 19, 2024
SKOUT® system
K240781 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 17, 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · EZL
Sentinel Medical Technologies, LLC
Gastroenterology & Urology · 100d
Cleared Apr 17, 2024
Enteral Feeding Sets
K240039 · KNT
Hangzhou Primecare Medical Co., Ltd.
Gastroenterology & Urology · 103d
Cleared Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
K233886 · FDT
Ambu A/S
Gastroenterology & Urology · 130d
Cleared Apr 15, 2024
Folysil Silicone Catheter
K233411 · EZL
Coloplast Corp.
Gastroenterology & Urology · 192d
Cleared Apr 12, 2024
Mobility+ Enteral Feeding System OTC
K233034 · PIF
Rockfield Medical
Gastroenterology & Urology · 200d
Cleared Apr 12, 2024
Disposable Injection Needles
K232200 · FBK
Ningbo Xinwell Medical Technology...
Gastroenterology & Urology · 262d
Cleared Apr 05, 2024
Ambu® aScope™ Gastro Large
K232919 · FDS
Ambu A/S
Gastroenterology & Urology · 199d
Cleared Apr 04, 2024
Agile Esophageal Stent System
K233837 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 122d