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) → PFJ — Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

# PFJ · Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

_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/PFJ

## Overview

- **Product Code:** PFJ
- **Device Name:** Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K143424](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PFJ/K143424.md) | UTAH CVX-RIPE | Utah Medical Products, Inc. | Aug 28, 2015 | SESE |
| [K131206](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PFJ/K131206.md) | COOK CERVICAL RIPENING BALLOON | Cook, Inc. | Sep 27, 2013 | SESE |

## Top Applicants

- Cook, Inc. — 1 clearance
- Utah Medical Products, Inc. — 1 clearance

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

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