← Product Code [HES](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES) · K862310

# CABOT MEDICAL VARIABLE FLOW INSUFFLATOR (K862310)

_Cabot Medical Corp. · HES · Aug 12, 1986 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K862310

## Device Facts

- **Applicant:** Cabot Medical Corp.
- **Product Code:** [HES](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES.md)
- **Decision Date:** Aug 12, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1300
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K862310](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K862310)

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