Clearance Summary
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) received FDA 510(k) clearance under submission number K233132, sponsored by Primus Sterilizer Company, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-12-19.
- Submission: K233132
- Applicant / Sponsor: Primus Sterilizer Company, LLC
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2023-12-19
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.