Clearance Summary
MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE received FDA 510(k) clearance under submission number K945102, sponsored by Alm Surgical Equipment, Inc.. 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 1994-11-04.
- Submission: K945102
- Applicant / Sponsor: Alm Surgical Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-11-04
Classification & Regulation
This clearance is catalogued under FDA product code FFS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.