510(k) K230015
K230015 is an FDA 510(k) premarket notification submitted by Laurane Medical Sas for the device "OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver". The FDA issued a decision of Substantially Equivalent on June 16, 2023. 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
- June 16, 2023
- Date Received
- January 3, 2023
- 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