K250387
- 510(k) number
- K250387
- Device name
- Remanufactured EndoWrist Long Tip Forceps (420048)
- Applicant
- Rebotix FL · US
- Product code
- QSM — System, Surgical, Computer Controlled Instrument, Re
- Decision date
- 2025-08-19
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250387.pdf
Official FDA record: K250387
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.