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510(k) K113872

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

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

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  • K063567 — EZ-MIO STERNAL (January 26, 2007)
  • K063142 — MANUAL PD-IO; POWERED PD-IO (December 8, 2006)
  • K062956 — EZ-MIO, EZ-IO DISTAL TIBIA (December 5, 2006)

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