MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML— 510(k) K121964

Name: FDA 510(k) clearance K121964
Creator: U.S. Food and Drug Administration
Published: 2013-01-23

Substantially Equivalent

Augmenix, Inc.

FDA 510(k) clearance K121964 for MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML, Substantially Equivalent on 2013-01-23. Applicant: Augmenix, Inc.. Device class: 2.

Clearance details

Applicant: Augmenix, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2012-07-05
Decision date: 2013-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.