Clearance Summary
UNIVERSAL SPECULUM HOLDER received FDA 510(k) clearance under submission number K822370, sponsored by Treace Medical, 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 1982-09-09.
- Submission: K822370
- Applicant / Sponsor: Treace Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.1800
- Decision date: 1982-09-09
Classification & Regulation
This clearance is catalogued under FDA product code EPY and 21 CFR 878.1800, within the General, Plastic Surgery review panel as a Class I device.