Medical Device Manufacturer · US , Chalotte , NC

Endochoice, Inc.

27 submissions · 25 cleared · Since 2010
27
Total
25
Cleared
0
Denied

Endochoice, Inc. — FDA 510(k) Submissions

Endochoice, Inc. has submitted 27 FDA 510(k) premarket notifications since 2010, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Air, Non-manual, For Endoscope, Endoscopic Irrigation/suction System, Colonoscope And Accessories, Flexible/rigid, Stents, Drains And Dilators For The Biliary Ducts, Snare, Flexible . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
Fuse Endoscopic System with FuseBox Processor
K160275 · PEA Endoscope, Accessories,... · Gastroenterology & Urology
Aug 2016 181d
EndoChoice Water Bottle Cap Irrigation System
K161482 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Jun 2016 27d
Seal Single-Use Biopsy Valve
K161167 · OCX Endoscopic... · Gastroenterology & Urology
May 2016 30d
SmartStart Air/Water and Suction Valves
K160403 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
May 2016 97d
EndoChoice Water Bottle Cap System
K153588 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Feb 2016 70d
EndoChoice Select Injection Needle
K151475 · FBK Endoscopic Injection... · Gastroenterology & Urology
Feb 2016 251d
Fuse Gastroscopy System
K152182 · FDS Gastroscope And... · Gastroenterology & Urology
Dec 2015 127d
rescuenet
K152580 · FDI Snare, Flexible · Gastroenterology & Urology
Nov 2015 54d
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K142155 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Jan 2015 167d
BONASTENT TRACHEAL / BRONCHIAL
K140472 · JCT Prosthesis, Tracheal,... · Anesthesiology
Oct 2014 234d
FUSE COLONOSCOPY SYSTEM
K141598 · FDF Colonoscope And... · Gastroenterology & Urology
Sep 2014 109d
BONASTENT BILIARY
K140760 · FGE Stents, Drains And... · Gastroenterology & Urology
Jun 2014 82d
SEAL SINGLE-USE BIOPSY VALVE
K133734 · OCX Endoscopic... · Gastroenterology & Urology
Mar 2014 100d
FUSE 1C COLONOSCOPY SYSTEM
K132839 · FDF Colonoscope And... · Gastroenterology & Urology
Feb 2014 149d
INJECTION NEEDLE
K132065 · FBK Endoscopic Injection... · Gastroenterology & Urology
Jan 2014 198d
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
K133747 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Jan 2014 30d
SEAL BIOPSY VALVE - REUSABLE
K132776 · OCX Endoscopic... · Gastroenterology & Urology
Dec 2013 106d
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Oct 2013 109d
PEERSCOPE SYSTEM
K131422 · FDS Gastroscope And... · Gastroenterology & Urology
Oct 2013 147d
AUTOBAND LIGATOR
K132535 · MND Ligator, Esophageal · Gastroenterology & Urology
Aug 2013 10d
EC SINGLE USE, POLYPECTOMY SNARE
K123223 · FDI Snare, Flexible · Gastroenterology & Urology
Jan 2013 87d
WATER BOTTLE CAP IRRIGATON SYSTEM
K120862 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Nov 2012 250d
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K112576 · FEQ Pump, Air, Non-manual,... · Gastroenterology & Urology
Jan 2012 141d
BIOPSY VALVE
K111821 · OCX Endoscopic... · Gastroenterology & Urology
Jul 2011 30d
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
K101298 · OCZ Endoscopic... · Gastroenterology & Urology
Aug 2010 87d
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