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
1897–1920 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 08, 2015
Ensizor Endoscopic Scissors
K150939 · OCZ
Slater Endoscopy, LLC
Gastroenterology & Urology · 62d
Cleared Jun 08, 2015
smARTrack Feeding Tube System
K142327 · KNT
Art Healthcare , Ltd.
Gastroenterology & Urology · 292d
Cleared Jun 05, 2015
MUSE System
K151001 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 51d
Cleared Jun 04, 2015
NxStage System One
K150472 · ODN
Nxstage Medical, Inc.
Gastroenterology & Urology · 101d
Cleared Jun 02, 2015
Injection Needle
K150434 · FBK
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 103d
Cleared Jun 01, 2015
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
K141531 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 357d
Cleared May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive...
K150679 · PIF
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared May 28, 2015
Vaginal Tactile Imager
K142355 · HIR
Advanced Tactile Imaging, Inc.
Gastroenterology & Urology · 276d
Cleared May 27, 2015
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic...
K150927 · OCY
Coloplast A/S
Gastroenterology & Urology · 51d
Cleared May 26, 2015
AMT Bridle - Nasal Tube Retention System
K142971 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 224d
Cleared May 22, 2015
Marrow Cellution Bone Marrow Aspiration Needle
K150563 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 77d
Cleared May 14, 2015
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · FDS
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 240d
Cleared May 13, 2015
JMS Harmony A.V. Fistula Needle Set
K151017 · FIE
JMS North America Corporation
Gastroenterology & Urology · 27d
Cleared May 11, 2015
Magic3 Go Intermittent Urinary Catheter
K150345 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 89d
Cleared May 04, 2015
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
K141910 · KNW
Biologic Therapies, Inc.
Gastroenterology & Urology · 293d
Cleared May 01, 2015
Tablo Console with Wireless Capability
K150880 · KDI
Outset Medical
Gastroenterology & Urology · 30d
Cleared Apr 27, 2015
Medline Enteral Feeding Sets
K150286 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 81d
Cleared Apr 24, 2015
YARLAP
K141643 · KPI
International Trade Group, Inc.
Gastroenterology & Urology · 309d
Cleared Apr 20, 2015
TensCare KegelFit
K142506 · KPI
Tenscare, Ltd.
Gastroenterology & Urology · 224d
Cleared Apr 14, 2015
Sidecar External Working Channel
K150083 · FED
C2 Therapeutics
Gastroenterology & Urology · 89d
Cleared Apr 09, 2015
ApexM
K150183 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 72d
Cleared Apr 09, 2015
NeoMed NeoConnect Enteral Syringes with ENFit Connector
K143344 · PNR
Neomed, Inc.
Gastroenterology & Urology · 139d
Cleared Apr 02, 2015
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
K150010 · PIO
Cedic S.R.L.
Gastroenterology & Urology · 90d
Cleared Apr 02, 2015
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
K143018 · PIF
Covidien
Gastroenterology & Urology · 164d