510(k) K161482

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

K161482 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "EndoChoice Water Bottle Cap Irrigation System". The FDA issued a decision of Substantially Equivalent on June 27, 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
June 27, 2016
Date Received
May 31, 2016
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