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) → PON — Catheter, Balloon, Dilation Of Cervical Canal

# PON · Catheter, Balloon, Dilation Of Cervical Canal

_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/PON

## Overview

- **Product Code:** PON
- **Device Name:** Catheter, Balloon, Dilation Of Cervical Canal
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K202433](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PON/K202433.md) | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | Oct 15, 2021 | SESE |
| [K202427](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PON/K202427.md) | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | Nov 6, 2020 | SESE |
| [K190813](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PON/K190813.md) | CrossBay Cervical Dilator Catheter System | Crossbay Medical | Aug 23, 2019 | SESE |
| [K160664](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/PON/K160664.md) | Aqueduct 100 Cervical Dilator | Gtimd, LLC | Aug 1, 2016 | SESE |

## Top Applicants

- Gtimd, LLC — 3 clearances
- Crossbay Medical — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com