(287 days)
The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for the introduction of radionuclide seeds into the body for Brachytherapy procedures.
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This document is a 510(k) premarket notification letter from the FDA regarding the "Readi-Load System." It confirms that the device is substantially equivalent to legally marketed predicate devices.
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§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended 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.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.