FLAT DRAIN— 510(k) K813063

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K813063 for FLAT DRAIN, Substantially Equivalent on 1981-12-18. Applicant: Sil-Med Corp..

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GBW
Advisory panel: General, Plastic Surgery
Date received: 1981-10-30
Decision date: 1981-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

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.