← Product Code [HIH](/productcode/HIH) · K950255

# ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM (K950255)

_Argus Medical Co., Inc. · HIH · Aug 24, 1995 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K950255

## Device Facts

- **Applicant:** Argus Medical Co., Inc.
- **Product Code:** [HIH](/productcode/HIH.md)
- **Decision Date:** Aug 24, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1690
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

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**Source:** [https://fda.innolitics.com/device/K950255](https://fda.innolitics.com/device/K950255)

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