Search Results
Found 2 results
510(k) Data Aggregation
K Number
K190155Device Name
FibermarX Radiopaque Tissue Marker
Manufacturer
Date Cleared
2019-02-27
(28 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Viscus Biologics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FibermarX™ Radiopaque Tissue Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. In addition, the markers are indicated in situations where tissue needs to be marked for future medical procedures such as IMRT/IGRT.
Device Description
The device is a sterile, single-patient-use, barium sulfate infused non-absorbable polymer monofilament that is visible on standard radiographs (x-ray, CT, mammography). FibermarX™ is passed through soft tissue and tied into place during open, percutaneous, or arthroscopic/laparoscopic/endoscopic procedures and standard surgeon's knots or a continuous running outline are used to quickly mark the soft tissue for subsequent imaging or for radiotherapy target localization.
Ask a Question
Ask a specific question about this device
K Number
K170026Device Name
Radiopaque Tissue Marker
Manufacturer
Date Cleared
2017-06-02
(150 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Viscus Biologics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Radiopaque Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
The device is a sterile, single-patient-use, barium sulfate infused polypropylene suture that is radiopaque using standard radiographs (x-ray, mammography). The device is placed into soft tissue sites during open, percutaneous, or endoscopic procedures and standard surgeon's knots are tied to quickly and inexpensively mark the soft tissue so that the integrity and location of the marked soft tissue can be evaluated.
Ask a Question
Ask a specific question about this device
Page 1 of 1