510(k) K200278
K200278 is an FDA 510(k) premarket notification submitted by Praxis Medical, LLC for the device "CytoCore". The FDA issued a decision of Substantially Equivalent on March 31, 2020. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Praxis Medical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2020
- Date Received
- February 4, 2020
- 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