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
793–816 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 13, 2022
Telepack +
K221174 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 18d
Cleared May 13, 2022
HDF Assist Mudule, HDF Infusion Set and Substitution Filter
K210575 · KDI
Nephros
Gastroenterology & Urology · 441d
Cleared May 12, 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 267d
Cleared May 11, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 71d
Cleared May 09, 2022
Compass BDS Biliary Stent
K213946 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 143d
Cleared May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
K212582 · GCA
Boston Scientific Corporation
Gastroenterology & Urology · 263d
Cleared May 06, 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon /...
K211021 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 396d
Cleared Apr 29, 2022
Monarch Platform, Urology
K213334 · FGB
Auris Health, Inc.
Gastroenterology & Urology · 205d
Cleared Apr 29, 2022
BONREE Nelaton Catheter
K212430 · EZD
Bonree Medical Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Apr 26, 2022
SnapLoc Wire Lock
K213483 · ODC
Wilson Cook Medical
Gastroenterology & Urology · 179d
Cleared Apr 26, 2022
SpeedCath Compact Male
K210250 · EZD
Coloplast
Gastroenterology & Urology · 452d
Cleared Apr 22, 2022
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 15, 2022
Lilliput APD System
K212522 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 247d
Cleared Apr 13, 2022
Keffort (MC-100, MC-100A)
K213133 · KPI
Oriental Inspiration Limited
Gastroenterology & Urology · 198d
Cleared Apr 13, 2022
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible...
K212202 · FAJ
OTU Medical, Inc.
Gastroenterology & Urology · 273d
Cleared Apr 13, 2022
BIOTEQ Drainage Catheter BT-PDS-series
K210419 · FGE
Bioteque Corporation
Gastroenterology & Urology · 426d
Cleared Apr 11, 2022
G-EYE System
K220158 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 82d
Cleared Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
K213015 · FIE
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 200d
Cleared Apr 06, 2022
Balloon Dilatation Catheter
K213578 · FDF
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 147d
Cleared Apr 01, 2022
PuraStat-RM
K213552 · PHN
3-D Matrix, Inc.
Gastroenterology & Urology · 144d
Cleared Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
K212216 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 259d
Cleared Apr 01, 2022
HD-550 Video Endoscope System
K211882 · NWB
Sonoscape Medical Corp.
Gastroenterology & Urology · 284d
Cleared Apr 01, 2022
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and...
K210052 · FDF
Saneso, Inc.
Gastroenterology & Urology · 448d
Cleared Mar 29, 2022
Guidewire Locking Device
K220247 · ODC
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d