Resitu Slider 09 (RESL09)
FDA 510(k) clearance K252183 · decided 2025-09-24
Clearance details
- K-number
- K252183
- Device name
- Resitu Slider 09 (RESL09)
- Applicant
- Resitu Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2025-07-11
- Decision date
- 2025-09-24
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.