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510(k) K141910

Intraosseous Cannula System Bio-MAC¿ and Bio-CORE by Biologic Therapies, Inc. — Product Code KNW

K141910 is an FDA 510(k) premarket notification submitted by Biologic Therapies, Inc. for the device "Intraosseous Cannula System Bio-MAC¿ and Bio-CORE". The FDA issued a decision of Substantially Equivalent on May 4, 2015. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2015
Date Received
July 15, 2014
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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FDA data resources