510(k) K230646
K230646 is an FDA 510(k) premarket notification submitted by Uro-1 Medical, Inc. for the device "SUREcore Prime Biopsy Instrument". The FDA issued a decision of Substantially Equivalent on Nov 29, 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
- Nov 29, 2023
- Date Received
- Mar 8, 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