Clearance Summary
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE received FDA 510(k) clearance under submission number K011514, sponsored by Kencap , 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 2001-08-13.
- Submission: K011514
- Applicant / Sponsor: Kencap , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2001-08-13
Classification & Regulation
This clearance is catalogued under FDA product code KDD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.