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
313–336 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 15, 2025
PuraStat
K242634 · PHN
3-D Matrix Europe SAS
Gastroenterology & Urology · 134d
Cleared Jan 14, 2025
ASEPT® Glide Peritoneal Drainage System
K241278 · PNG
Pfm Medical, Inc.
Gastroenterology & Urology · 253d
Cleared Jan 10, 2025
ZZIREN™ Orogastric Tube
K242901 · KNT
Tools For Surgery, LLC
Gastroenterology & Urology · 109d
Cleared Jan 10, 2025
Triopsy Actuator (TMSDGB)
K242228 · KNW
Triopsy Medical, Inc.
Gastroenterology & Urology · 164d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 168d
Cleared Jan 02, 2025
Haemostasis Clips
K241005 · PKL
Jiangxi Zhuoruihua Medical Instrument...
Gastroenterology & Urology · 265d
Cleared Dec 20, 2024
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
K243607 · FJK
Diality, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 20, 2024
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · OCZ
Envision Endoscopy
Gastroenterology & Urology · 87d
Cleared Dec 20, 2024
Single-use Balloon Dilatation Catheter
K241888 · FGE
Leo Medical Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Dec 19, 2024
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · PNR
Cardinalhealth
Gastroenterology & Urology · 23d
Cleared Dec 19, 2024
Nutrifit
K243361 · FPD
Vygon USA
Gastroenterology & Urology · 51d
Cleared Dec 18, 2024
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R,...
K242535 · FAJ
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 114d
Cleared Dec 17, 2024
Tornus ES
K241801 · FGE
Asahi Intecc Co., Ltd.
Gastroenterology & Urology · 179d
Cleared Dec 17, 2024
Cntrl+ Bladder Support Pessary
K240798 · HHW
Cntrl+, Inc.
Gastroenterology & Urology · 270d
Cleared Dec 16, 2024
Extraction Basket
K243471 · LQR
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 38d
Cleared Dec 13, 2024
Uro-G HD Cystoscope (1520)
K243196 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 73d
Cleared Dec 13, 2024
Gastro Concepts Air Assist
K242668 · FER
Gastro Concepts, LLC
Gastroenterology & Urology · 99d
Cleared Dec 12, 2024
Aqua Medical RF Vapor Ablation System
K241271 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 220d
Cleared Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
K242950 · FGE
Boston Scientific
Gastroenterology & Urology · 74d
Cleared Dec 06, 2024
NanoKnife Generator (H78720300301US0)
K242687 · OAB
AngioDynamics, Inc.
Gastroenterology & Urology · 91d
Cleared Dec 06, 2024
RED
K242304 · KLA
Neuraxis, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 06, 2024
PeritX™ 1L Drainage Kit (90-1010)
K241946 · PNG
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
K241213 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 220d
Cleared Dec 04, 2024
CapsoCam Plus (SV-3) Capsule Endoscopy System
K242643 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 92d