Clearance Summary
The VersaJet II Hydrosurgery System received FDA 510(k) clearance under submission number K143115, sponsored by Smith & Nephew, Inc.. 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 2015-07-15.
- Submission: K143115
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 2015-07-15
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.