Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5380](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5380) → HHS — Transcervical Contraceptive Tubal Occlusion Device

# HHS · Transcervical Contraceptive Tubal Occlusion Device

_Obstetrics/Gynecology · 21 CFR 884.5380 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHS

## Overview

- **Product Code:** HHS
- **Device Name:** Transcervical Contraceptive Tubal Occlusion Device
- **Regulation:** [21 CFR 884.5380](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5380)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **Implant:** yes

## Identification

A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020014](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHS/P020014.md) | ESSURE SYSTEM | Bayer Pharma AG | Nov 4, 2002 | APPR |

## Top Applicants

- Bayer Pharma AG — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHS](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHS)

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