← Product Code [HGS](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGS) · K914387

# TRANSCERVICAL INTRAUTERINE KIT (K914387)

_Telos Medical Corp. · HGS · Dec 30, 1991 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGS/K914387

## Device Facts

- **Applicant:** Telos Medical Corp.
- **Product Code:** [HGS](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGS.md)
- **Decision Date:** Dec 30, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.2700
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGS/K914387](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGS/K914387)

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