FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Gastroenterology & Urology ×
9,917 results
1–24 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 02, 2026
Plenity-V (MC0979 / GS110)
K261783 · QFQ
Gelesis SRL
Gastroenterology & Urology · 126d
Cleared Oct 02, 2026
Hemostatic Clip
K261741 · PKL
Anrei Medical (Hz) Co., Ltd.
Gastroenterology & Urology · 128d
Cleared Oct 02, 2026
stentFIX System Set (100.50n)
K260487 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 231d
Cleared Sep 30, 2026
Rapid Barostat Bag (RBB) Pump and Catheter System
K262621 · FFX
Mui Scientific, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 30, 2026
danumed StomaMeter
K262038 · KNT
Danumed Medizintechnik GmbH
Gastroenterology & Urology · 105d
Cleared Sep 25, 2026
CapsoView (CVV)
K254230 · QZF
CapsoVision, Inc.
Gastroenterology & Urology · 270d
Cleared Sep 23, 2026
BTL-299-F
K262353 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 75d
Cleared Sep 23, 2026
Liquick X-treme, Liquick X-treme Plus
K261418 · EZD
Teleflex Medical
Gastroenterology & Urology · 146d
Cleared Sep 18, 2026
Pathfinder Endoscope Overtube
K262262 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 18, 2026
Drainage Catheter
K254179 · FGE
Canyon Medical, Inc.
Gastroenterology & Urology · 269d
Cleared Sep 17, 2026
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
K262913 · FGE
Medtronic, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 16, 2026
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K262877 · GEX
Olympus Surgical Technologies America
Gastroenterology & Urology · 30d
Cleared Sep 16, 2026
Ambu® aScope™ Gastro
K261400 · FDS
Ambu A/S
Gastroenterology & Urology · 140d
Cleared Sep 15, 2026
CVAC® Aspiration System
K261447 · FGB
Calyxo, Inc.
Gastroenterology & Urology · 137d
Cleared Sep 14, 2026
colonic FTRD Set (200.70)
K253481 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 335d
Cleared Sep 12, 2026
CADDIE
K260133 · QNP
Odin Medical Limited
Gastroenterology & Urology · 239d
Cleared Sep 11, 2026
Single Use Ureteral Access Sheath
K260410 · FED
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 214d
Cleared Sep 10, 2026
danumed Extension Set for Gastrostomy Button
K260110 · PIF
Danumed Medizintechnik GmbH
Gastroenterology & Urology · 239d
Cleared Sep 10, 2026
Irrigation/Urology Sets
K254111 · LJH
B.Braun Medical, Inc.
Gastroenterology & Urology · 265d
Cleared Sep 09, 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3,...
K262488 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 51d
Cleared Sep 09, 2026
QF10
K261470 · NHV
E.A.M Benelux B.V
Gastroenterology & Urology · 128d
Cleared Sep 09, 2026
SIS BLU (SISBLU-30-01)
K260997 · PLL
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 167d
Cleared Sep 04, 2026
Gastric Alimetry
K262292 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 59d
Cleared Sep 04, 2026
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
K260756 · EZL
Sentinel Medical Technologies,
Gastroenterology & Urology · 179d