510(k) K213896

BD Trek Powered Bone Biopsy System by Bard Peripheral Vascular — Product Code KNW

K213896 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular for the device "BD Trek Powered Bone Biopsy System". The FDA issued a decision of Substantially Equivalent on March 30, 2022. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bard Peripheral Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2022
Date Received
December 14, 2021
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