510(k) K192101
K192101 is an FDA 510(k) premarket notification submitted by Medax Srl Unipersonale for the device "Medone Ultra, Medextra". The FDA issued a decision of Substantially Equivalent on Apr 2, 2020. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Medax Srl Unipersonale has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 2, 2020
- Date Received
- Aug 5, 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
- 510(k)