← Product Code [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ) · K871216

# HILARIS-NORI ENDOMETRIAL APPLICATOR (K871216)

_Mick Radio-Nuclear Instruments, Inc. · IWJ · Jul 21, 1987 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K871216

## Device Facts

- **Applicant:** Mick Radio-Nuclear Instruments, Inc.
- **Product Code:** [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ.md)
- **Decision Date:** Jul 21, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5650
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K871216](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K871216)

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