510(k) K101832

BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT by Medical Device Technologies, Inc. — Product Code KNW

K101832 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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