510(k) K212079
K212079 is an FDA 510(k) premarket notification submitted by Teesuvac Aps for the device "TeesuVac Breast Biopsy Device Mark 1". The FDA issued a decision of Substantially Equivalent on Feb 2, 2022. 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
- Feb 2, 2022
- Date Received
- Jul 2, 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
- 510(k)