AART NASAL IMPLANT— 510(k) K021418

Name: FDA 510(k) clearance K021418
Creator: U.S. Food and Drug Administration
Published: 2002-07-02

Substantially Equivalent

Aesthetic and Reconstructive Technologies, Inc.

FDA 510(k) clearance K021418 for AART NASAL IMPLANT, Substantially Equivalent on 2002-07-02. Applicant: Aesthetic and Reconstructive Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Aesthetic and Reconstructive Technologies, Inc.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 2002-05-03
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aesthetic and Reconstructive Technologies, Inc.

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K023678 — DIMISIL SCAR GEL2003-01-23
K022306 — AART SILICONE TUBING2002-10-10
K022511 — AART CALF IMPLANT2002-08-26
K022223 — AART SILICONE SHEETING2002-08-08
K021820 — AART SILICONE CARVING BLOCK2002-07-16

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.