510(k) K113872

THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE by Vidacare Corporation — Product Code KNW

K113872 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE". The FDA issued a decision of Substantially Equivalent on March 8, 2012. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Vidacare Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2012
Date Received
December 30, 2011
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