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EndoChoice, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0694-2016Class IIFuse 1C ColonoscopeDecember 18, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K160275Fuse Endoscopic System with FuseBox ProcessorAugust 1, 2016
K161482EndoChoice Water Bottle Cap Irrigation SystemJune 27, 2016
K161167Seal Single-Use Biopsy ValveMay 26, 2016
K160403SmartStart Air/Water and Suction ValvesMay 19, 2016
K153588EndoChoice Water Bottle Cap SystemFebruary 24, 2016
K151475EndoChoice Select Injection NeedleFebruary 8, 2016
K152182Fuse Gastroscopy SystemDecember 10, 2015
K152580rescuenetNovember 3, 2015
K142155ENDOCHOICE WATER BOTTLE CAP SYSTEMJanuary 20, 2015
K140472BONASTENT TRACHEAL / BRONCHIALOctober 17, 2014
K141598FUSE COLONOSCOPY SYSTEMSeptember 30, 2014
K140760BONASTENT BILIARYJune 16, 2014
K133734SEAL SINGLE-USE BIOPSY VALVEMarch 19, 2014
K132839FUSE 1C COLONOSCOPY SYSTEMFebruary 6, 2014
K132065INJECTION NEEDLEJanuary 17, 2014
K133747ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEMJanuary 8, 2014
K132776SEAL BIOPSY VALVE - REUSABLEDecember 20, 2013
K131991ENDOCHOICE HOT BIOPSY FORCEPSOctober 15, 2013
K131422PEERSCOPE SYSTEMOctober 10, 2013
K132535AUTOBAND LIGATORAugust 23, 2013