Clearance Summary
GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 received FDA 510(k) clearance under submission number K853291, sponsored by Bio-Detek, Inc.. 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 1985-10-10.
- Submission: K853291
- Applicant / Sponsor: Bio-Detek, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1985-10-10
Classification & Regulation
This clearance is catalogued under FDA product code HAM and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.