STERIS TEN SIXTEEN STEAM STERILIZER— 510(k) K982332

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K982332 for STERIS TEN SIXTEEN STEAM STERILIZER, Substantially Equivalent on 1999-01-20. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1998-07-02
Decision date: 1999-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.