Clearance Summary
WISEBANDS SKIN CLOSURE DEVICE received FDA 510(k) clearance under submission number K002315, sponsored by Wisebands , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-03-15.
- Submission: K002315
- Applicant / Sponsor: Wisebands , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4320
- Decision date: 2001-03-15
Classification & Regulation
This clearance is catalogued under FDA product code MKY and 21 CFR 878.4320, within the General, Plastic Surgery review panel as a Class I device.