Clearance Summary
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette received FDA 510(k) clearance under submission number K223015, sponsored by Plasmapp Co,., Ltd.. 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 2023-05-09.
- Submission: K223015
- Applicant / Sponsor: Plasmapp Co,., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6860
- Decision date: 2023-05-09
Classification & Regulation
This clearance is catalogued under FDA product code MLR and 21 CFR 880.6860, within the General Hospital review panel as a Class II device.