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
1129–1152 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 20, 2019
Paragonix SherpaPak Pancreas Transport System
K191440 · KDN
Paragonix Technologies
Gastroenterology & Urology · 204d
Cleared Dec 20, 2019
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI...
K190805 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 266d
Cleared Dec 19, 2019
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
K190829 · FBK
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 262d
Cleared Dec 18, 2019
IntraMarX Radiopaque Markers
K191087 · FFX
Anx Robotica Corp
Gastroenterology & Urology · 238d
Cleared Dec 17, 2019
Single Use Balloon Dilator V (with knife)
K193039 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Dec 16, 2019
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · LJE
Cook Incorporated
Gastroenterology & Urology · 252d
Cleared Dec 13, 2019
Tri-Ex Extraction Balloon with Multiple Sizing
K193344 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 10d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Dec 13, 2019
VaPro Plus Pocket, VaPro Plus
K193148 · GBM
Hollister Incorporated
Gastroenterology & Urology · 30d
Cleared Dec 12, 2019
Tablo Hemodialysis System, Tablo Cartridge
K190793 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 259d
Cleared Dec 11, 2019
FUJIFILM Distal Cap Models 33-40
K193123 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Dec 06, 2019
EQUINOX Balloon Dilatation Catheter
K190612 · EZN
Dornier Medtech America, Inc.
Gastroenterology & Urology · 270d
Cleared Dec 04, 2019
Medline Quick Switch Valve with ENFit Connector
K191759 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 04, 2019
RELiZORB
K191379 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 195d
Cleared Dec 02, 2019
Uroject12 Syringe Lever
K190987 · QBL
Urogen Pharma, Ltd.
Gastroenterology & Urology · 231d
Cleared Dec 02, 2019
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via...
K190659 · FAD
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 263d
Cleared Nov 27, 2019
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter
K192468 · GBM
Hangzhou Bever Medical Devices Co., Ltd.
Gastroenterology & Urology · 79d
Cleared Nov 25, 2019
SOZO
K190529 · QJB
ImpediMed Limited
Gastroenterology & Urology · 266d
Cleared Nov 22, 2019
Navina Smart System, Navina Classic System
K190977 · KNT
Dentsply Sirona
Gastroenterology & Urology · 221d
Cleared Nov 22, 2019
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
K190512 · FDI
Intelligent Endoscopy
Gastroenterology & Urology · 266d
Cleared Nov 20, 2019
FUJIFILM Endoscope Model EC-760Z-V/L
K192664 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 56d
Not Cleared Nov 20, 2019
EchoTip Insight Portosystemic Pressure Gradient Measuring System
DEN180062 · QIJ
Cook Ireland, Ltd.
Gastroenterology & Urology · 366d
Cleared Nov 15, 2019
Pentax Medical Video Duodenoscope ED34-i10T2
K192245 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 15, 2019
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784 · PIF
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 135d