Clearance Summary
Electro-Spec Steri-Caps received FDA 510(k) clearance under submission number K231905, sponsored by Electro-Spec, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-08-14.
- Submission: K231905
- Applicant / Sponsor: Electro-Spec, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2023-08-14
Classification & Regulation
This clearance is catalogued under FDA product code HTY and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.