Clearance Summary
NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six received FDA 510(k) clearance under submission number K152340, sponsored by North American Rescue, LLC. 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 2016-05-31.
- Submission: K152340
- Applicant / Sponsor: North American Rescue, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2016-05-31
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.