Clearance Summary
GS-5200 HOOK SUCTION/COAGULATOR, 5MM received FDA 510(k) clearance under submission number K900954, sponsored by Solos Endoscopy, 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 1990-04-18.
- Submission: K900954
- Applicant / Sponsor: Solos Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1990-04-18
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.