SECRMARK BIOPSY SITE MARKING SYSTEM— 510(k) K102768

Name: FDA 510(k) clearance K102768
Creator: U.S. Food and Drug Administration
Published: 2010-12-02

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K102768 for SECRMARK BIOPSY SITE MARKING SYSTEM, Substantially Equivalent on 2010-12-02. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2010-09-24
Decision date: 2010-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, 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.