PRIMUS STEAM STERILIZERS— 510(k) K991575

Substantially Equivalent

Primus Sterilizer Co., Inc.

FDA 510(k) clearance K991575 for PRIMUS STEAM STERILIZERS, Substantially Equivalent on 1999-12-03. Applicant: Primus Sterilizer Co., Inc..

Clearance details

Applicant: Primus Sterilizer Co., Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1999-05-06
Decision date: 1999-12-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.