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510(k) Data Aggregation
K Number
K063177Device Name
RAPID STRAND RX
Manufacturer
ONCURA INC.
Date Cleared
2006-11-30
(42 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
ONCURA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RAPID Strand™ Rx is a device specifically made in accordance with a medical specialist's written prescription, specified dose and design characteristics. It is intended to be use only for an individual named patient and for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary tunnors, which are low to moderate racterestable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand™ Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Device Description
RAPID Strand™ Rx is consists of absorbable seeding spacers and radionuclide brachytherapy sources spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method. The apparent activity of the seed ranges from 0.191 to 1.01 mCi that correspond air kerma strength value of 0.243 to 1.285 µGym2/h per seed. RAPID Strand™ RX is sterilized and ready to be use when shipped. RAPID Strand™ Rx should not be re-sterilized.
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