Clearance Summary
KEISEI SCALPEL (STERILE AND NON-STERILE) received FDA 510(k) clearance under submission number K863213, sponsored by Keisei Medical Industrial Co., 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 1986-09-02.
- Submission: K863213
- Applicant / Sponsor: Keisei Medical Industrial Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-09-02
Classification & Regulation
This clearance is catalogued under FDA product code GDX and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.