← Product Code [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH) · K954164

# HYSTEROSCOPE (K954164)

_Conceptus, Inc. · HIH · Mar 12, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K954164

## Device Facts

- **Applicant:** Conceptus, Inc.
- **Product Code:** [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH.md)
- **Decision Date:** Mar 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1690
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology
- **Attributes:** Therapeutic

## Indications for Use

The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.

## Device Story

Rigid hysteroscope with flexible articulating tip; telescopic optical system; conveys images to user eye or video camera; used by physicians in clinical settings for diagnostic and operative uterine procedures; enables direct visualization of cervical canal and uterine cavity.

## Technological Characteristics

Rigid shaft with flexible articulating tip; telescopic optical system; includes eyepiece plug and light guide plug; manual operation.

## 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.

## Submission Summary (Full Text)

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MAR 12 1996

# Conceptus K954164

## Conceptus Hysteroscope
## Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.

The Conceptus hysteroscope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user’s eye or to a video camera.

The intended use, optics, design, materials, specifications and mode of operation of the Conceptus Hysteroscope were found to be substantially equivalent to several predicate hysteroscopes.

K954164

Conceptus, Inc. • 1021 Howard Avenue, San Carlos, CA 94070 Phone:415/802-7240 Fax:415/802-7272
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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K954164](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K954164)

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