FibermarX Radiopaque Tissue Marker
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190155 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FibermarX Radiopaque Tissue Marker is a radiopaque marker designed for surgical implantation to provide radiographic visualization of tissue locations. It serves as a reference frame for stereotactic radiosurgery, radiotherapy, and other image-guided procedures, ensuring precise localization of treatment targets or future intervention sites.
This single-patient-use, sterile device is constructed from blue polypropylene and is visible on standard radiographic imaging, including x-ray, mammography, and CT scans. It is intended for use during open, percutaneous, arthroscopic, laparoscopic, or endoscopic procedures, where it is passed through soft tissue and secured in place. The device is classified under FDA regulation 892.5050 and holds a Traditional 510(k) clearance (K190155) for radiology applications.
Frequently asked questions
What types of procedures can the FibermarX Radiopaque Tissue Marker be used in, and why is it particularly useful in those settings?
The FibermarX Radiopaque Tissue Marker is designed for use during open, percutaneous, arthroscopic, laparoscopic, or endoscopic procedures. It is particularly useful in these settings because it provides radiographic visualization of tissue locations, serving as a reference frame for stereotactic radiosurgery, radiotherapy, and other image-guided interventions. This ensures precise localization of treatment targets or future intervention sites, which is critical in minimally invasive and complex surgeries where accurate anatomical reference is essential.
Is the FibermarX Radiopaque Tissue Marker reusable, or is it intended for single-patient use? How does this affect its handling and storage?
The FibermarX Radiopaque Tissue Marker is explicitly designed for single-patient-use only, meaning it must not be reused after implantation in one patient. This classification ensures sterility and safety, requiring proper handling and storage in a sterile, sealed packaging until use. After opening, it should be used immediately and discarded to prevent contamination or cross-infection risks.
How is the FibermarX Radiopaque Tissue Marker visible on imaging, and what types of scans can it be seen on?
The FibermarX Radiopaque Tissue Marker is constructed from blue polypropylene, a material that is radiopaque, meaning it appears clearly on standard radiographic imaging. It is visible on x-ray, mammography, and CT scans, making it suitable for a wide range of diagnostic and treatment planning applications where precise anatomical localization is required.
What regulatory pathway was followed for the FDA clearance of the FibermarX Radiopaque Tissue Marker, and what does this mean for its use in clinical settings?
The FibermarX Radiopaque Tissue Marker received FDA clearance through a Traditional 510(k) pathway (K190155), classified under regulation 892.5050 and categorized under the Radiology advisory committee. This means the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets established safety and performance standards for radiopaque markers. Clinically, this clearance confirms its compliance with FDA requirements for use in radiographic visualization during surgical and interventional procedures.
What material is the FibermarX Radiopaque Tissue Marker made from, and does its color affect its visibility or functionality?
The FibermarX Radiopaque Tissue Marker is made from blue polypropylene, a material chosen for its radiopacity and durability. The blue color is not merely aesthetic—it enhances visibility under certain lighting conditions during surgical procedures, making it easier to identify and manipulate in the operating field. However, its primary function relies on the radiopacity of the polypropylene, ensuring clear visualization on radiographic imaging.
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: FibermarX™ Tissue Marker | Viscus Biologics, FibermarX Radiopaque Tissue Marker - medical-xprt.com, ECM Biomaterials & Product Realization | Viscus Biologics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190155 | Class II | Active |
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Manufacturer
- Manufacturer
- Viscus Biologics, LLC
Sources (1)
- FDA 510(k) K190155 24 fields · synced Sep 19, 2026