Clearance Summary
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER received FDA 510(k) clearance under submission number K972109, sponsored by General Surgical Innovations. 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 1997-11-14.
- Submission: K972109
- Applicant / Sponsor: General Surgical Innovations
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1997-11-14
Classification & Regulation
This clearance is catalogued under FDA product code FZW and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.