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) → HGF — Source, Abortion Unit, Vacuum

# HGF · Source, Abortion Unit, Vacuum

_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/HGF

## Overview

- **Product Code:** HGF
- **Device Name:** Source, Abortion Unit, Vacuum
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945179](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGF/K945179.md) | BOTTLE COLLECTION SET | Medgyn Products, Inc. | Jan 26, 1995 | SESE |
| [K905115](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGF/K905115.md) | BIOVISION ENDOCULAR PROBE | Douglas James Donaldson Compliance Services | Feb 11, 1991 | SESE |
| [K904248](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGF/K904248.md) | MODEL GLASE 210 HOLMIUM LASER SYSTEM | Charles L. Rose and Co., Inc. | Dec 14, 1990 | SESE |
| [K890787](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGF/K890787.md) | O-020 LASER INDIRECT OPHTHALMOSCOPE | Hgm Medical Laser Systems, Inc. | Mar 24, 1989 | SESE |

## Top Applicants

- Charles L. Rose and Co., Inc. — 1 clearance
- Douglas James Donaldson Compliance Services — 1 clearance
- Hgm Medical Laser Systems, Inc. — 1 clearance
- Medgyn Products, Inc. — 1 clearance

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

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