510(k) K051637

DSNARE, MODEL 00711087 by United States Endoscopy Group, Inc. — Product Code FCK

K051637 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "DSNARE, MODEL 00711087". The FDA issued a decision of Substantially Equivalent on October 31, 2005. 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
October 31, 2005
Date Received
June 20, 2005
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