K250539
- 510(k) number
- K250539
- Device name
- Remanufactured EndoWrist Tenaculum Forceps (420207)
- Applicant
- Rebotix FL · US
- Product code
- QSM — System, Surgical, Computer Controlled Instrument, Re
- Decision date
- 2025-08-19
- Date received
- 2025-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250539.pdf
Official FDA record: K250539
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.