VARIODRAIN— 510(k) K810636

Substantially Equivalent

Colmed, Ltd.

FDA 510(k) clearance K810636 for VARIODRAIN, Substantially Equivalent on 1981-05-01. Applicant: Colmed, Ltd..

Clearance details

Applicant: Colmed, Ltd.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1981-03-10
Decision date: 1981-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.