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

Clearance details

Applicant

Somatex Medical Technologies GmbH

Product code

Code NEU

Device class

Class 2

Regulation

21 CFR 878.4300

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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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 →