Clearance Summary
VERSAJET Hydrosurgery System (III) received FDA 510(k) clearance under submission number K220964, sponsored by Smith & Nephew Medical Limited. 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 2023-05-16.
- Submission: K220964
- Applicant / Sponsor: Smith & Nephew Medical Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 2023-05-16
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.