Chrysalis Intelligence · Sponsors · Somatex Medical Technologies GmbH

Somatex Medical Technologies GmbH

Berlin, DE · 1 510(k) clearances · 1 recalls

Total clearances
1
2021-02-18 → 2021-02-18
Last 12 months
0
Product codes
1
Most recent
2021-02-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NEU Marker, Radiographic, Implantable Class II General, Plastic Surgery 1 2021-02-18
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2021-02-03
DateSeverityStatusRecall # ProductCodeReason
2021-02-03 Class II Terminated Z-1200-2021 Thread-like wire marker This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-02-18 K201863 Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape NEU Class II General, Plastic Surgery