TraceIT Tissue Marker - 3mL— 510(k) K151998

Name: FDA 510(k) clearance K151998
Creator: U.S. Food and Drug Administration
Published: 2015-08-19

Substantially Equivalent

Augmenix, Inc.

FDA 510(k) clearance K151998 for TraceIT Tissue Marker - 3mL, Substantially Equivalent on 2015-08-19. 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: 2015-07-20
Decision date: 2015-08-19
Decision: Substantially Equivalent
Clearance type: Special
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.