510(k) K163052
K163052 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Brevera Biopsy System with Corlumina Imaging Technology". The FDA issued a decision of Substantially Equivalent on Mar 29, 2017. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Hologic, Inc. has 119 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2017
- Date Received
- Nov 1, 2016
- 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
- 510(k)