Tumark Vision— 510(k) K180443
Substantially EquivalentSomatex Medical Technologies GmbH
FDA 510(k) clearance K180443 for Tumark Vision, Substantially Equivalent on 2018-03-22. 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
- Special
- Location
- Teltow, DE
Recent devices under product code NEU
view allMore clearances from Somatex Medical Technologies GmbH
view all- K201863 — Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
- K182082 — Tumark for Eviva, Tumark for Brevera
- K111692 — TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
- K102771 — BIOPSY HANDY, MRI BIOPSY HANDY
- K093064 — TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.