K233700
- 510(k) number
- K233700
- Device name
- Avicenna Roboflex
- Applicant
- Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi TR
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-08-16
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.