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
505–528 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 21, 2023
RELiZORB®
K232784 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 101d
Cleared Dec 21, 2023
Defendo Fujifilm 700 Single Use Biopsy Valve
K232329 · ODC
Medivators (A Subsidiary of Steris...
Gastroenterology & Urology · 140d
Cleared Dec 20, 2023
Perifit Care+
K231780 · HIR
X6 Innovations
Gastroenterology & Urology · 187d
Cleared Dec 18, 2023
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 453d
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Dec 14, 2023
PhySoftAMS®
K232283 · MQS
Physician Software Systems, LLC
Gastroenterology & Urology · 136d
Cleared Dec 14, 2023
Disposable Hot Biopsy Forceps
K231721 · KGE
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 184d
Cleared Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...
K233645 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Not Cleared Dec 12, 2023
NaviCam ProScan
DEN230027 · QZF
Ankon Technologies Co., Ltd.
Gastroenterology & Urology · 242d
Cleared Dec 08, 2023
Vibrant System
K232830 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 86d
Cleared Dec 06, 2023
2008T BlueStar Hemodialysis Machine
K231125 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 230d
Cleared Dec 05, 2023
Tablo® Hemodialysis System
K233335 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 67d
Cleared Dec 01, 2023
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502,...
K233159 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 65d
Cleared Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249 · ODC
Pentax of America, Inc.
Gastroenterology & Urology · 126d
Cleared Nov 30, 2023
LumenEye® X1 endoscope (LX1-SCP-203)
K232262 · FAN
Surgease Innovations Limited
Gastroenterology & Urology · 122d
Cleared Nov 29, 2023
Disposable Endoscope Valves System
K232244 · ODC
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 124d
Cleared Nov 29, 2023
SUREcore Prime Biopsy Instrument
K230646 · KNW
Uro-1 Medical, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 28, 2023
Gold Probe Bipolar Electrohemostasis Catheter
K232633 · KNS
Boston Scientific
Gastroenterology & Urology · 90d
Cleared Nov 24, 2023
Passio Pump Drainage System
K230319 · PNG
Bearpac Medical
Gastroenterology & Urology · 291d
Cleared Nov 22, 2023
Disposable Endoscope Valves Kit
K222499 · ODC
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 461d
Cleared Nov 21, 2023
Endoscopy Irrigation Tubing
K230773 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 245d
Cleared Nov 17, 2023
Gastric Alimetry System
K232925 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 59d
Cleared Nov 17, 2023
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100)
K232028 · FDS
Iq Endoscopes Limited
Gastroenterology & Urology · 133d
Cleared Nov 16, 2023
Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
K232945 · NIE
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 57d