510(k) K120862

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

K120862 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "WATER BOTTLE CAP IRRIGATON SYSTEM". The FDA issued a decision of Substantially Equivalent on November 27, 2012. 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
November 27, 2012
Date Received
March 22, 2012
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