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
385–408 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 15, 2024
Reusable Interface Cable 1.5 m (PRD-IFC-002)
K242061 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 31d
Cleared Aug 02, 2024
Disposable Ureteral Guide Sheath
K241181 · FED
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 95d
Cleared Aug 02, 2024
Moda-flx Hemodialysis System and Cartridge
K233798 · KDI
Diality, Inc.
Gastroenterology & Urology · 247d
Cleared Aug 01, 2024
KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2)
K241945 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 29d
Cleared Aug 01, 2024
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
K240805 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 129d
Cleared Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 231d
Cleared Aug 01, 2024
Rüsch Latex Gold Foley Catheter
K232469 · EZL
Teleflexmedical, Inc.
Gastroenterology & Urology · 352d
Cleared Jul 31, 2024
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach...
K241934 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 29d
Cleared Jul 29, 2024
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 26, 2024
Luja female (20051)
K241028 · EZD
Coloplast
Gastroenterology & Urology · 102d
Cleared Jul 25, 2024
GI Genius™ Module 100 (GGM100.US)
K241887 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 27d
Cleared Jul 25, 2024
KARL STORZ Fiber Telescopes for Urology
K233372 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 297d
Cleared Jul 24, 2024
CADDIE
K240044 · QNP
Odin Medical Limited
Gastroenterology & Urology · 201d
Cleared Jul 16, 2024
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible...
K233778 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 232d
Cleared Jul 12, 2024
Endoscopic Video Image Processor (RP-IPD-V2000EF)
K241500 · FAJ
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 45d
Cleared Jul 12, 2024
HemoCare Bicarbonate Concentrate Set (BCS)
K240920 · KPO
Deka Research and Development
Gastroenterology & Urology · 99d
Cleared Jul 12, 2024
“MoFi” Cell Culture Basal Medium
K240247 · NDS
Duogenic Stemcells Corporation
Gastroenterology & Urology · 164d
Cleared Jul 12, 2024
Single Use Hemoclips
K234124 · PKL
Promisemed Hangzhou Meditech Co., Ltd.
Gastroenterology & Urology · 197d
Cleared Jul 12, 2024
HemoCare Hemodialysis System
K233557 · KDI
Deka Research and Development
Gastroenterology & Urology · 249d
Cleared Jul 03, 2024
Blue Eye
K241591 · PLL
The Standard Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 03, 2024
SKOUT® system
K241508 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 36d
Cleared Jul 03, 2024
Gastric Alimetry
K240946 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 89d
Cleared Jul 03, 2024
Disposable Enteral Feeding Sets
K240052 · PIF
Beijing L&Z Medical Technology...
Gastroenterology & Urology · 177d
Cleared Jul 01, 2024
Single-use Video Ureterorenoscope (SVU-220US)
K241639 · FGB
Huger Medical Instrument Co., Ltd.
Gastroenterology & Urology · 24d