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
193–216 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 08, 2025
Aqua Medical RF Vapor Ablation System
K251226 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 01, 2025
AK 98 Dialysis Machine (955607)
K250508 · KDI
Vantive US Healthcare, LLC
Gastroenterology & Urology · 161d
Cleared Jul 23, 2025
Resilience Fully Covered Esophageal Stent System
K251265 · ESW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 22, 2025
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
K243367 · PBP
Minnesota Medical Technologies
Gastroenterology & Urology · 265d
Cleared Jul 18, 2025
Profoject™ Enteral Feeding Syringe
K251585 · PNR
CMT Health PTE., Ltd.
Gastroenterology & Urology · 56d
Cleared Jul 18, 2025
InstaFAN
K251542 · ODG
Onepass Medical , Ltd.
Gastroenterology & Urology · 59d
Cleared Jul 16, 2025
Suction Valve (MAJ-1443)
K250949 · ODC
Olympus Medical Systems Corporation
Gastroenterology & Urology · 110d
Cleared Jul 16, 2025
ARCHIMEDES Biodegradable Pancreatic Stent
K243412 · FGE
Q3 Medical USA, LLC (C/O Q3 Medical...
Gastroenterology & Urology · 257d
Cleared Jul 09, 2025
Flexiva Pulse Laser Fiber
K251759 · GEX
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jul 08, 2025
Single-use Ureteral Access Sheath
K250695 · FED
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 123d
Cleared Jul 03, 2025
Single-use Ureteral Access Sheath
K251599 · FED
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 37d
Cleared Jul 03, 2025
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K251291 · FGE
Boston Scientific
Gastroenterology & Urology · 69d
Cleared Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · LJE
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 135d
Cleared Jul 01, 2025
Cure Twist Female 8 Catheter (T8)
K250699 · EZD
Convatec
Gastroenterology & Urology · 116d
Cleared Jun 27, 2025
Luja Coudé
K251116 · EZD
Coloplast Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 2025
LumenaTM Ureteral Access Sheath
K250585 · FED
Cathegenix (Xiamen) Co., Ltd.
Gastroenterology & Urology · 120d
Cleared Jun 27, 2025
Multi4 System
K250522 · FAS
Multi4 Medical AB
Gastroenterology & Urology · 126d
Cleared Jun 27, 2025
Disposable Distal Cap
K243388 · FDS
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 239d
Cleared Jun 26, 2025
Atmo Gas Capsule System
K250940 · NYV
Atmo Biosciences, Ltd.
Gastroenterology & Urology · 90d
Cleared Jun 26, 2025
Disposable Intermittent Catheter (TPU Catheter)
K243175 · EZD
Chengdu Daxan Innovative Medical...
Gastroenterology & Urology · 269d
Cleared Jun 26, 2025
NeuroTrac® MyoPlus Pro (MYO120U)
K243079 · KPI
Verity Medical , Ltd.
Gastroenterology & Urology · 269d
Cleared Jun 25, 2025
EGIS Biliary Double Bare Stent (BDB080405)
K242845 · FGE
S&G Biotech, Inc.
Gastroenterology & Urology · 278d
Cleared Jun 20, 2025
Disposable Endoscopy Valve Set
K250732 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 101d
Cleared Jun 18, 2025
Ureteral Stents (AF-D series)
K243039 · FAD
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 264d