PRIMUS PSS SERIES STERILIZERS— 510(k) K926185

Substantially Equivalent

Primus Sterilizer Co., Inc.

FDA 510(k) clearance K926185 for PRIMUS PSS SERIES STERILIZERS, Substantially Equivalent on 1994-05-09. Applicant: Primus Sterilizer Co., Inc..

Clearance details

Applicant: Primus Sterilizer Co., Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1992-12-08
Decision date: 1994-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omaha, NE, US

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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.