Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730) → NMP — Needle, Isotope, Reprocessed

# NMP · Needle, Isotope, Reprocessed

_Radiology · 21 CFR 892.5730 · Class 2_

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

## Overview

- **Product Code:** NMP
- **Device Name:** Needle, Isotope, Reprocessed
- **Regulation:** [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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