KMD-MARK1 TISSUE MARKER— 510(k) K093473

Name: FDA 510(k) clearance K093473
Creator: U.S. Food and Drug Administration
Published: 2010-07-02

Substantially Equivalent

Kent Medical Devices, Inc.

FDA 510(k) clearance K093473 for KMD-MARK1 TISSUE MARKER, Substantially Equivalent on 2010-07-02. Applicant: Kent Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Kent Medical Devices, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2009-11-06
Decision date: 2010-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NEU

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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.