AMSCO POLARIS SL— 510(k) K854922

Name: FDA 510(k) clearance K854922
Creator: U.S. Food and Drug Administration
Published: 1986-01-24

Substantially Equivalent

Amsco Co.

FDA 510(k) clearance K854922 for AMSCO POLARIS SL, Substantially Equivalent on 1986-01-24. Applicant: Amsco Co.. Device class: 2.

Clearance details

Applicant: Amsco Co.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1985-12-10
Decision date: 1986-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.