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 884.4260](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4260) → PKN — Dilator, Cervical, Synthetic, Osmotic

# PKN · Dilator, Cervical, Synthetic, Osmotic

_Obstetrics/Gynecology · 21 CFR 884.4260 · Class 2_

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

## Overview

- **Product Code:** PKN
- **Device Name:** Dilator, Cervical, Synthetic, Osmotic
- **Regulation:** [21 CFR 884.4260](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4260)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

A hygroscopic Laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K143447](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PKN/K143447.md) | Dilapan-S | Medicem Technology S.R.O | Apr 17, 2015 | SESE |

## Top Applicants

- Medicem Technology S.R.O — 1 clearance

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

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