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

Name: FDA 510(k) clearance K863942
Creator: U.S. Food and Drug Administration
Published: 1986-10-24

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K863942 for POREX(TM) NOSE PROSTHESIS, Substantially Equivalent on 1986-10-24. Applicant: Porex Medical. Device class: 2.

Clearance details

Applicant: Porex Medical
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
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

Download summary PDF View on FDA.gov ↗

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More clearances from Porex Medical

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K872791 — POREX NERVE LOCATOR1987-10-20
K873044 — POREX OTOLOGY INSTRUMENTS1987-09-04
K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS1987-08-21
K863943 — POREX(TM) EYE SPHERE IMPLANT1987-02-27
K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT1987-02-27

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.