Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4500](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4500) → HGA — Cranioclast

# HGA · Cranioclast

_Obstetrics/Gynecology · 21 CFR 884.4500 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGA

## Overview

- **Product Code:** HGA
- **Device Name:** Cranioclast
- **Regulation:** [21 CFR 884.4500](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4500)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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