510(k) K101146

WATER BOTTLE CAP SYSTEM by United States Endoscopy Group, Inc. — Product Code FEQ

K101146 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "WATER BOTTLE CAP SYSTEM". The FDA issued a decision of Substantially Equivalent on July 16, 2010. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2010
Date Received
April 23, 2010
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