PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)— 510(k) K233132

Name: FDA 510(k) clearance K233132
Creator: U.S. Food and Drug Administration
Published: 2023-12-19

Substantially Equivalent

Primus Sterilizer Company, LLC

FDA 510(k) clearance K233132 for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB), Substantially Equivalent on 2023-12-19. Applicant: Primus Sterilizer Company, LLC. Device class: 2.

Clearance details

Applicant: Primus Sterilizer Company, LLC
Product code: Product code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2023-09-27
Decision date: 2023-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.