510(k) K193268
K193268 is an FDA 510(k) premarket notification submitted by Apriomed AB for the device "APrioCore Plus". The FDA issued a decision of Substantially Equivalent on February 27, 2020. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Apriomed AB has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2020
- Date Received
- November 26, 2019
- 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