FORTADERM WOUND DRESSING— 510(k) K011026

Substantially Equivalent

Organogenesis, Inc.

FDA 510(k) clearance K011026 for FORTADERM WOUND DRESSING, Substantially Equivalent on 2001-06-13. Applicant: Organogenesis, Inc..

Clearance details

Applicant: Organogenesis, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2001-04-04
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.