MIXED MEDIA MARKER— 510(k) K102506

Name: FDA 510(k) clearance K102506
Creator: U.S. Food and Drug Administration
Published: 2011-01-12

Substantially Equivalent

Cortex Manufacturing, Inc.

FDA 510(k) clearance K102506 for MIXED MEDIA MARKER, Substantially Equivalent on 2011-01-12. Applicant: Cortex Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Cortex Manufacturing, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2010-09-01
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Stevens, WA, US

Download summary PDF View on FDA.gov ↗

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K100267 — FLEXIMARC, MODEL CM-0.9-2-10-GG-L2010-02-24

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.