Clearance Summary
MRI FASTSYSTEM RETRACTOR SYSTEM received FDA 510(k) clearance under submission number K001339, sponsored by Omni-Tract Surgical, Div. Minn. Scientific, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2000-05-17.
- Submission: K001339
- Applicant / Sponsor: Omni-Tract Surgical, Div. Minn. Scientific, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2000-05-17
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.