DeviceClearance

TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560— 510(k) K073095

Substantially Equivalent

Somatex Medical Technologies GmbH

FDA 510(k) clearance K073095 for TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560, Substantially Equivalent on 2008-03-19. Applicant: Somatex Medical Technologies GmbH. Device class: 2.

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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NEU

product code NEU
Injury
824
Total
824

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K073095

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073095.

Data sourced from openFDA. This site is unofficial and independent of the FDA.