MILLENNIUM GOLD— 510(k) K992090

Name: FDA 510(k) clearance K992090
Creator: U.S. Food and Drug Administration
Published: 1999-09-08

Substantially Equivalent

Skytron, Div. the Kmw Group, Inc.

FDA 510(k) clearance K992090 for MILLENNIUM GOLD, Substantially Equivalent on 1999-09-08. Applicant: Skytron, Div. the Kmw Group, Inc.. Device class: 2.

Clearance details

Applicant: Skytron, Div. the Kmw Group, Inc.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1999-06-21
Decision date: 1999-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, 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.