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 884.5070](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5070) → HGH — Cannula, Suction, Uterine

# HGH · Cannula, Suction, Uterine

_Obstetrics/Gynecology · 21 CFR 884.5070 · Class 2_

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

## Overview

- **Product Code:** HGH
- **Device Name:** Cannula, Suction, Uterine
- **Regulation:** [21 CFR 884.5070](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5070)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K172151](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K172151.md) | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | Apr 9, 2018 | SESE |
| [K161106](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K161106.md) | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | Jan 13, 2017 | SESE |
| [K140213](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K140213.md) | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | Mar 25, 2015 | SESE |
| [K093508](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K093508.md) | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | Womancare Global | Mar 4, 2010 | SESE |
| [K935820](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K935820.md) | KOLSTER METHODS | Kolster Methods | Jul 19, 1994 | SESE |
| [K840285](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGH/K840285.md) | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | May 9, 1984 | SESE |

## Top Applicants

- Chongquin Jinshan Science & Technology (Group) Co., Ltd. — 1 clearance
- Dongguan Microview Medical Technology Co., Ltd. — 1 clearance
- Imex Medical Systems, Inc. — 1 clearance
- Kolster Methods — 1 clearance
- Panpac Medical Corporation — 1 clearance

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

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