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
553–576 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 05, 2023
MFG-05
K230780 · KPI
Zimmer Medizinsysteme GmbH
Gastroenterology & Urology · 197d
Not Cleared Oct 04, 2023
DuraGraft
DEN230002 · QEJ
Marizyme, Inc.
Gastroenterology & Urology · 274d
Cleared Oct 03, 2023
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach...
K231960 · QKZ
Anx Robotica Corporation
Gastroenterology & Urology · 92d
Cleared Sep 29, 2023
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible...
K231702 · FAJ
OTU Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Sep 27, 2023
EndoGI S-Path Biliary Stent System
K232596 · FGE
Endogi Medical, Ltd.
Gastroenterology & Urology · 33d
Cleared Sep 27, 2023
Disposable Injection Needle AF series
K230925 · FBK
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 177d
Cleared Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
K231891 · OTM
Coloplast
Gastroenterology & Urology · 90d
Cleared Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
K232558 · PEW
Neotract, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 21, 2023
Pelvic Floor Muscle Stimulator
K230767 · KPI
Nanjing Vishee Medical Technology...
Gastroenterology & Urology · 185d
Cleared Sep 21, 2023
Servator P Plus SALF Solution
K230193 · KDN
S.A.L.F. Spa
Gastroenterology & Urology · 240d
Cleared Sep 21, 2023
EGIS Biliary Single Bare Stent
K223354 · FGE
S&G Biotech, Inc.
Gastroenterology & Urology · 323d
Cleared Sep 20, 2023
TULSA-PRO System
K230692 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 191d
Cleared Sep 18, 2023
Apollo ESG NXT System, Apollo REVISE NXT System
K232544 · QTD
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 27d
Cleared Sep 15, 2023
Over-tube (TR-1208A)
K230752 · FED
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 182d
Cleared Sep 15, 2023
Ambu® aScope™ Colon
K230332 · FDF
Ambu A/S
Gastroenterology & Urology · 220d
Cleared Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 30d
Cleared Sep 14, 2023
TEA Device
K230526 · QHH
Transtimulation Research, Inc.
Gastroenterology & Urology · 199d
Cleared Sep 12, 2023
Stone Extraction Baskets
K230598 · LQR
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 193d
Cleared Sep 08, 2023
Air/Water Bottle Tubing, CO2 Source Tubing
K231471 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 109d
Cleared Sep 08, 2023
KARL STORZ Urological Laser Accessories
K230535 · GEX
Karl Storz SE & CO. KG
Gastroenterology & Urology · 193d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 261d
Cleared Sep 06, 2023
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic...
K230127 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 232d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 30d
Cleared Aug 31, 2023
Ancora-SB
K231323 · FDA
Aspero Medical, Inc.
Gastroenterology & Urology · 115d