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510(k) Data Aggregation
K Number
K092041Device Name
STELLAR FIDUCIAL MARKER, MODEL GFMIA
Manufacturer
Date Cleared
2009-10-02
(87 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
STELLAR MEDICAL LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The needles are used for interstitial placement of gold fiducial markers. Once implanted, the gold fiducial markers are used as localization targets for the process in IMRT, and IGRT radiation therapy.
Device Description
The Stellar Fiducial Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of a solid gold marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax. The packaged needles are sterilized via ethylene oxide.
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