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510(k) K072045

ONCONTROL BONE MARROW BIOPSY SYSTEM by Vidacare Corporation — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2007
Date Received
July 25, 2007
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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  • K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO (July 27, 2010)
  • K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, (October 14, 2009)
  • K081713 — VERTEBRAL ACCESS SYSTEM BY VIDACARE (November 21, 2008)
  • K070759 — POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM (May 21, 2007)
  • 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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