Primus Healthcare Sterilizer PSS11-HC
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221474 FDA 510(k)
- FDA Product Code
- FLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6880 FDA 510(k)
- Regulation Number
- 880.6880 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Primus Healthcare Sterilizer Model PSS11-HC is a steam sterilizer designed for the sterilization of non-porous and porous, heat, and moisture-stable materials. It is intended for use in hospital settings, central sterile departments, and surgery centers.
This device is authorized under FDA 510(k) clearance K221474. It is classified as a Class 2 steam sterilizer under regulation number 880.6880.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRIMUS brand PSS11 Series Healthcare Steam Sterilizers: High ..., PDF PSS11-HC Steam Sterilizer FOR HEALTHCARE APPLICATIONS, PDF PSS11-HC Healthcare Sterilizer - Spire Integrated Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221474 | Class II | Active |
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Manufacturer
- Manufacturer
- Primus Sterilizer Company, LLC
Sources (1)
- FDA 510(k) K221474 24 fields · synced Sep 26, 2026