Clearance Summary
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL received FDA 510(k) clearance under submission number K080317, sponsored by Syntheon, LLC. 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 2008-04-29.
- Submission: K080317
- Applicant / Sponsor: Syntheon, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2008-04-29
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.