POREX(TM) NOSE PROSTHESIS— 510(k) K863942

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K863942 for POREX(TM) NOSE PROSTHESIS, Substantially Equivalent on 1986-10-24. Applicant: Porex Medical.

Clearance details

Applicant: Porex Medical
Product code: Code FZE
Advisory panel: General, Plastic Surgery
Date received: 1986-10-10
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, US

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.