Clearance Summary
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE received FDA 510(k) clearance under submission number K060782, sponsored by Smith & Nephew Wound Management. 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 2006-04-12.
- Submission: K060782
- Applicant / Sponsor: Smith & Nephew Wound Management
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 2006-04-12
Classification & Regulation
This clearance is catalogued under FDA product code FQH and 21 CFR 880.5475, within the General Hospital review panel as a Class II device.