CASTLE SERIES 100HC STEAM STERILIZERS— 510(k) K994314

Substantially Equivalent

Getinge/Castle, Inc.

FDA 510(k) clearance K994314 for CASTLE SERIES 100HC STEAM STERILIZERS, Substantially Equivalent on 2000-02-16. Applicant: Getinge/Castle, Inc..

Clearance details

Applicant: Getinge/Castle, Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1999-12-22
Decision date: 2000-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, 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.