510(k) K153588

EndoChoice Water Bottle Cap System by Endochoice, Inc. — Product Code FEQ

K153588 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "EndoChoice Water Bottle Cap System". The FDA issued a decision of Substantially Equivalent on February 24, 2016. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Endochoice, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2016
Date Received
December 16, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Air, Non-Manual, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type