Clearance Summary
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 received FDA 510(k) clearance under submission number K032680, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-09-26.
- Submission: K032680
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-09-26
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.