Clearance Summary
SMITH & NEPHEW INSTRUMENT TRAYS received FDA 510(k) clearance under submission number K092551, sponsored by Smith & Nephew Inc., Endoscopy Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-09-14.
- Submission: K092551
- Applicant / Sponsor: Smith & Nephew Inc., Endoscopy Div.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2010-09-14
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.