Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart D — Obstetrical and Gynecological Prosthetic Devices](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices) → [21 CFR 884.3650](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/884.3650) → HFJ — Prosthesis, Fallopian Tube

# HFJ · Prosthesis, Fallopian Tube

_Obstetrics/Gynecology · 21 CFR 884.3650 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFJ

## Overview

- **Product Code:** HFJ
- **Device Name:** Prosthesis, Fallopian Tube
- **Regulation:** [21 CFR 884.3650](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/884.3650)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **Implant:** yes

## Identification

A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932114](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFJ/K932114.md) | TUBAL LUMEN SUPPORT | Cook Ob/Gyn | Sep 27, 1994 | SESE |

## Top Applicants

- Cook Ob/Gyn — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
