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
961–984 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 10, 2021
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
K201809 · KDI
Baxter Healthcare Corportation
Gastroenterology & Urology · 252d
Cleared Mar 05, 2021
Andorate Universal Endoscope Tip Guard
K202838 · OCU
Ga Health Company Limited
Gastroenterology & Urology · 161d
Cleared Feb 25, 2021
Vortek Single Loop Ureteral Stent
K201436 · FAD
Coloplast Corp.
Gastroenterology & Urology · 269d
Cleared Feb 19, 2021
ClearCap Distal Attachment
K202616 · OCX
Finemedix Co., Ltd.
Gastroenterology & Urology · 163d
Cleared Feb 18, 2021
EsoCheck Cell Collection Device
K210137 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 05, 2021
Sphincterotome
K201121 · KNS
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 284d
Cleared Jan 15, 2021
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For...
K201897 · FGB
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 191d
Cleared Jan 15, 2021
VMCore Biopsy Needle
K201650 · KNW
Uro-1, Inc.
Gastroenterology & Urology · 211d
Cleared Jan 14, 2021
Lockado Repositionable Hemostasis Clip
K202333 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 150d
Cleared Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
K202104 · ODC
STERIS Corporation
Gastroenterology & Urology · 169d
Cleared Jan 13, 2021
MyOnyx System
K201014 · KPI
Thought Technology , Ltd.
Gastroenterology & Urology · 271d
Cleared Jan 08, 2021
BioGuard Air/Water and Suction Valves
K203630 · ODC
Steris Corporations
Gastroenterology & Urology · 28d
Cleared Jan 06, 2021
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
K200769 · ODC
Wilson Instruments (Sha) Co., Ltd.
Gastroenterology & Urology · 287d
Cleared Jan 06, 2021
Applied Medical Anoscope
K200021 · FER
Applied Medical Resources
Gastroenterology & Urology · 366d
Cleared Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical...
K203166 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 68d
Cleared Dec 30, 2020
Foley Balloon Catheter for Urology
K201776 · EZL
Apollon Co., Ltd.
Gastroenterology & Urology · 184d
Cleared Dec 28, 2020
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K203062 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 80d
Cleared Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
K200426 · MPB
Health Line International Corporation
Gastroenterology & Urology · 307d
Cleared Dec 23, 2020
Locking device
K202237 · ODC
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 138d
Cleared Dec 23, 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K193670 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 358d
Not Cleared Dec 23, 2020
EndoRotor Device
DEN200016 · QNE
Interscope, Inc.
Gastroenterology & Urology · 282d
Cleared Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 56d
Cleared Dec 17, 2020
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165 · LJE
Coloplast Corp.
Gastroenterology & Urology · 230d
Cleared Dec 16, 2020
Disposable Stone Extraction basket
K201509 · LQR
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 194d