← Product Code [KXK](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK) · K010283

# THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 (K010283)

_Theragenics Corp. · KXK · Apr 26, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K010283

## Device Facts

- **Applicant:** Theragenics Corp.
- **Product Code:** [KXK](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK.md)
- **Decision Date:** Apr 26, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5730
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory 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.

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K010283](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K010283)

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