Clearance Summary
SAFETY NEEDLE SHEATH received FDA 510(k) clearance under submission number K904198, sponsored by Concord/Portex. 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 1990-12-19.
- Submission: K904198
- Applicant / Sponsor: Concord/Portex
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1990-12-19
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.