510(k) K072045

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

K072045 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "ONCONTROL BONE MARROW BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 2007. 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
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