Clearance Summary
ALLEN UNIVERSAL STIRRUP received FDA 510(k) clearance under submission number K860177, sponsored by Edgewater Medical Equipment Systems. 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 1986-02-11.
- Submission: K860177
- Applicant / Sponsor: Edgewater Medical Equipment Systems
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1986-02-11
Classification & Regulation
This clearance is catalogued under FDA product code BWN and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.