510(k) K103326

MULTIPLE BIOPSY SYSTEM by United States Endoscopy Group, Inc. — Product Code FCK

K103326 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "MULTIPLE BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 6, 2011. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2011
Date Received
November 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Suction
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type