TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC— 510(k) K111692

Substantially Equivalent

Somatex Medical Technologies GmbH

FDA 510(k) clearance K111692 for TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC, Substantially Equivalent on 2011-11-08. Applicant: Somatex Medical Technologies GmbH.

Clearance details

Applicant: Somatex Medical Technologies GmbH
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2011-06-16
Decision date: 2011-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Wurmlingen, DE

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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.