W & H LISA STEAM STERILIZER— 510(k) K022816

Substantially Equivalent

A-Dec, Inc.

FDA 510(k) clearance K022816 for W & H LISA STEAM STERILIZER, Substantially Equivalent on 2003-02-07. Applicant: A-Dec, Inc..

Clearance details

Applicant: A-Dec, Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2002-08-26
Decision date: 2003-02-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Newberg, OR, 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.