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 884.4250](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4250) → HDN — Dilator, Cervical, Expandable

# HDN · Dilator, Cervical, Expandable

_Obstetrics/Gynecology · 21 CFR 884.4250 · Class 3_

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

## Overview

- **Product Code:** HDN
- **Device Name:** Dilator, Cervical, Expandable
- **Regulation:** [21 CFR 884.4250](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4250)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.

## Classification Rationale

Class III (premarket approval).

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

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