Clearance Summary
SPONGETRAC received FDA 510(k) clearance under submission number K964181, sponsored by Surgitrac Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1997-02-26.
- Submission: K964181
- Applicant / Sponsor: Surgitrac Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2740
- Decision date: 1997-02-26
Classification & Regulation
This clearance is catalogued under FDA product code MRL and 21 CFR 880.2740, within the General Hospital review panel as a Class I device.