510(k) K260572
K260572 is an FDA 510(k) premarket notification submitted by Medimetrix, LLC for the device "Marrow Marxman". The FDA issued a decision of Substantially Equivalent on Aug 4, 2026. 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
- Aug 4, 2026
- Date Received
- Feb 19, 2026
- 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)