MONARCH NASAL IMPLANT— 510(k) K041690

Substantially Equivalent

Hanson Medical, Inc.

FDA 510(k) clearance K041690 for MONARCH NASAL IMPLANT, Substantially Equivalent on 2005-02-11. Applicant: Hanson Medical, Inc..

Clearance details

Applicant: Hanson Medical, Inc.
Product code: Code FZE
Advisory panel: General, Plastic Surgery
Date received: 2004-06-22
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, WA, 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.