Clearance Summary
Avicenna Roboflex received FDA 510(k) clearance under submission number K233700, sponsored by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-08-16.
- Submission: K233700
- Applicant / Sponsor: Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2024-08-16
Classification & Regulation
This clearance is catalogued under FDA product code FGB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.