Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093064 FDA 510(k)
- FDA Product Code
- NEU FDA 510(k)
- Models / Variants
- 271560 FDA 510(k)Mr-Tumark Professional FDA 510(k)Model 601560 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tumark Professional is a Radiographic, Implantable Marker designed for soft tissue attachment during open or percutaneous surgical procedures. It provides a visible reference point for radiographic and radiological identification of the surgical site, particularly in breast procedures. The device aids in precise localization and tracking of anatomical landmarks post-surgery.
These markers are supplied sterile and intended for single-use. The MR-Tumark Professional variant is MRI-safe, allowing for post-procedural imaging without interference. Models 271560 and 601560 are classified under FDA 510(k) clearance (K093064) and fall under regulation 878.4300. They are distributed as reusable packaging for sterile field use, adhering to Class II medical device standards for radiographic markers.
Frequently asked questions
What types of surgical procedures is the Tumark Professional marker designed to assist with, and how does it help during these procedures?
The Tumark Professional marker is specifically designed for soft tissue attachment during open or percutaneous surgical procedures, particularly in breast surgeries. It provides a visible reference point for radiographic and radiological identification of the surgical site, aiding in precise localization and tracking of anatomical landmarks post-surgery. This helps surgeons and radiologists ensure accurate follow-up imaging and treatment planning.
Are the Tumark Professional markers reusable or single-use, and how are they supplied?
The Tumark Professional markers are intended for single-use only. They are supplied sterile in reusable packaging, which is meant to maintain a sterile field during surgical procedures. This ensures each marker remains uncontaminated and ready for immediate use.
What distinguishes the MR-Tumark Professional model from the standard Tumark Professional model?
The MR-Tumark Professional model (601560) is specifically designed to be MRI-safe, allowing for post-procedural imaging without interference. This makes it ideal for patients who require follow-up MRI scans after surgery, whereas the standard Tumark Professional (271560) does not have this MRI compatibility.
What regulatory pathway was followed for FDA clearance of the Tumark Professional markers, and what classification do they fall under?
The Tumark Professional markers (models 271560 and 601560) were cleared through the FDA’s 510(k) pathway, specifically under the traditional review process. They are classified as Class II medical devices under the FDA’s regulation number 878.4300, which pertains to radiographic markers. The clearance number is K093064.
How should the Tumark Professional markers be stored before use, and what precautions should be taken?
The Tumark Professional markers are supplied sterile and packaged for sterile field use. They should be stored in their original packaging in a clean, dry environment, protected from physical damage and contamination. The packaging ensures sterility until the marker is opened for immediate surgical use, so it should not be reused or repackaged.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tumark Professional, Model 271560, Mr-tumark Professional, Model 601560 ..., Tumark Professional, Model 271560; Mr- Tumark Professional, Model ..., Somatex Tumark Professional Instructions For Use Manual, Tumark Professional, Model 271560; Mr- Tumark Professional, Model ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093064 | Class II | Active |
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Manufacturer
- Manufacturer
- SOMATEX Medical Technologies GmbH
Sources (1)
- FDA 510(k) K093064 24 fields · synced Oct 6, 2026