K252183
- 510(k) number
- K252183
- Device name
- Resitu Slider 09 (RESL09)
- Applicant
- Resitu Medical AB SE
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-09-24
- Date received
- 2025-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K252183.pdf
Official FDA record: K252183
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.