510(k) K213896
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