Clearance Summary
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES received FDA 510(k) clearance under submission number K994084, sponsored by Smith & Nephew, 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 2000-01-20.
- Submission: K994084
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-01-20
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.