Clearance Summary
PUSH-ON NEEDLE 30GX8MM received FDA 510(k) clearance under submission number K120191, sponsored by Scandinavian Health Limited. 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 2012-05-23.
- Submission: K120191
- Applicant / Sponsor: Scandinavian Health Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2012-05-23
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.