ENVICLUSIVE (TM)— 510(k) K874554

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K874554 for ENVICLUSIVE (TM), Substantially Equivalent on 1988-03-11. Applicant: Marion Laboratories, Inc..

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1987-11-04
Decision date: 1988-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MI, US

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.