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
241–264 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 16, 2025
Byonyks X-1 APD Cycler
K243371 · FKX
Byonyks Pvt, Ltd.
Gastroenterology & Urology · 198d
Cleared May 16, 2025
Hemodialysis Catheter
K241581 · MSD
Haolang Medical USA Corporation
Gastroenterology & Urology · 347d
Cleared May 15, 2025
NeurAxis IB-Stim (01-1020)
K250451 · QHH
Neuraxis
Gastroenterology & Urology · 86d
Cleared May 15, 2025
Colonovideoscope (CF-EZ1500DL)
K250432 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
K242479 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 267d
Cleared May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
K242176 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 295d
Cleared May 15, 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 296d
Cleared May 14, 2025
Disposable ureteral stent
K243830 · FAD
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 152d
Cleared May 09, 2025
SKOUT system
K251126 · QNP
Iterative Health
Gastroenterology & Urology · 28d
Cleared May 06, 2025
Single-use Flexible Ureteroscope
K250785 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 53d
Cleared May 05, 2025
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure...
K240447 · MLW
Thermasolutions, LLC
Gastroenterology & Urology · 445d
Cleared May 02, 2025
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1)
K244001 · FBO
Karl Storz SE & CO. KG
Gastroenterology & Urology · 127d
Cleared May 02, 2025
F88 URE-SD/RD Flexible Ureteroscope
K243894 · FGB
Sg Endoscopy Pte, Ltd.
Gastroenterology & Urology · 135d
Cleared May 01, 2025
Disposable Distal Attachment D-201 Series
K250296 · FDS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 01, 2025
X°Port Lung Preservation System
K243870 · KDN
Traferox Technologies, Inc.
Gastroenterology & Urology · 135d
Cleared Apr 29, 2025
PUMA-G Pediatric System
K242211 · KGC
Coaptech, Inc.
Gastroenterology & Urology · 274d
Cleared Apr 28, 2025
LumiRex Ureteroscope
K243532 · FGB
Contra Healthcare Solutions, LLC
Gastroenterology & Urology · 164d
Cleared Apr 25, 2025
DCX Disposable Cassette (DCX)
K243998 · KDN
Institut Geroges Lopez
Gastroenterology & Urology · 120d
Cleared Apr 25, 2025
DHF 0.2 Hemoconcentrator (DHF 02)
K243264 · KDI
Sorin Group Italia S.R.L.
Gastroenterology & Urology · 192d
Cleared Apr 23, 2025
EchoGuide (Version 1)
K243479 · IYO
Sonavex, Inc.
Gastroenterology & Urology · 166d
Cleared Apr 18, 2025
PADLOCK CLIP EFTR Kit (00713229)
K250842 · PKL
STERIS Corporation
Gastroenterology & Urology · 29d
Cleared Apr 18, 2025
Extension Feeding Set with ENFit™ Connectors
K250481 · PIF
SKY Medical, a.s.
Gastroenterology & Urology · 58d
Cleared Apr 17, 2025
RELiZORB (100300/100301)
K250499 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 17, 2025
Luja Set
K250270 · EZD
Coloplast Corp.
Gastroenterology & Urology · 77d