510(k) K252183
K252183 is an FDA 510(k) premarket notification submitted by Resitu Medical AB for the device "Resitu Slider 09 (RESL09)". The FDA issued a decision of Substantially Equivalent on September 24, 2025. 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
- September 24, 2025
- Date Received
- July 11, 2025
- 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