MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS— 510(k) K082278

Substantially Equivalent

Ethicon Endo-Sugery, LLC

FDA 510(k) clearance K082278 for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS, Substantially Equivalent on 2008-12-16. Applicant: Ethicon Endo-Sugery, LLC.

Clearance details

Applicant: Ethicon Endo-Sugery, LLC
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2008-08-11
Decision date: 2008-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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.