Clearance Summary
ProteXsure Safety Capsule System received FDA 510(k) clearance under submission number K152597, sponsored by Starcap Medical, LLC ( Dba Prism Medical & Design). 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 2016-06-08.
- Submission: K152597
- Applicant / Sponsor: Starcap Medical, LLC ( Dba Prism Medical & Design)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2016-06-08
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.