Clearance Summary
Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) received FDA 510(k) clearance under submission number K240881, sponsored by Covidien (Part of Medtronic). 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 2024-11-01.
- Submission: K240881
- Applicant / Sponsor: Covidien (Part of Medtronic)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 878.4740
- Decision date: 2024-11-01
Classification & Regulation
This clearance is catalogued under FDA product code GAG and 21 CFR 878.4740, within the General Hospital review panel as a Class II device.