MONARCH NASAL IMPLANT— 510(k) K041690

Name: FDA 510(k) clearance K041690
Creator: U.S. Food and Drug Administration
Published: 2005-02-11

Substantially Equivalent

Hanson Medical, Inc.

FDA 510(k) clearance K041690 for MONARCH NASAL IMPLANT, Substantially Equivalent on 2005-02-11. Applicant: Hanson Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hanson Medical, Inc.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
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

Download summary PDF View on FDA.gov ↗

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K161548 — Osseointegrated Fixtures2016-12-01
K090803 — HANSON MEDICAL FACIAL IMPLANTS2010-06-30
K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)2009-06-02
K071018 — MONARCH NASAL IMPLANT2007-05-25

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K030808 — HANSON MEDICAL CALF IMPLANT2003-04-21
K030809 — HANSON MEDICAL GLUTEAL IMPLANT2003-04-21
K973729 — POWERFLEX PEC IMPLANT1997-12-24

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.