Clearance Summary
DISP. ELECTROSURGERY PENCIL, HAND CONTROL received FDA 510(k) clearance under submission number K900633, sponsored by Medical/Surgical Specialties, 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 1990-05-07.
- Submission: K900633
- Applicant / Sponsor: Medical/Surgical Specialties, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1990-05-07
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.