510(k) K142125
K142125 is an FDA 510(k) premarket notification submitted by Medax Srl Unipersonale for the device "New Medax Biopsy Systems". The FDA issued a decision of Substantially Equivalent on Dec 22, 2015. 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
- Dec 22, 2015
- Date Received
- Aug 4, 2014
- 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)