Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869— 510(k) K213545

Name: FDA 510(k) clearance K213545
Creator: U.S. Food and Drug Administration
Published: 2023-02-02

Substantially Equivalent

Steelco S.P.A.

FDA 510(k) clearance K213545 for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869, Substantially Equivalent on 2023-02-02. Applicant: Steelco S.P.A.. Device class: 2.

Clearance details

Applicant: Steelco S.P.A.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2021-11-08
Decision date: 2023-02-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Riese Pio X, IT

Download summary PDF View on FDA.gov ↗

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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.