K233132 is an FDA 510(k) clearance for the PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB). This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Primus Sterilizer Company, LLC (Orlando, US). The FDA issued a Cleared decision on December 19, 2023, 83 days after receiving the submission on September 27, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K233132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | December 19, 2023 |
| Days to Decision | 83 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |