510(k) K142155

ENDOCHOICE WATER BOTTLE CAP SYSTEM by Endochoice, Inc. — Product Code FEQ

K142155 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 January 20, 2015. 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
January 20, 2015
Date Received
August 6, 2014
Clearance Type
Traditional
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