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) → HDY — Dilator, Cervical, Hygroscopic-Laminaria

# HDY · Dilator, Cervical, Hygroscopic-Laminaria

_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/HDY

## Overview

- **Product Code:** HDY
- **Device Name:** Dilator, Cervical, Hygroscopic-Laminaria
- **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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K040625](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K040625.md) | ATAD ARD CATHETER | Atad Developments , Ltd. | Jan 18, 2005 | SESE |
| [K021012](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K021012.md) | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | Jun 25, 2002 | SESE |
| [K011512](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K011512.md) | MMODIFICATION TO LAMINARIA | A & A Medical, Inc. | Jul 9, 2001 | SESE |
| [K955072](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K955072.md) | LAMINARIA | Cti Corp., Ltd. | May 22, 1996 | SESE |
| [K892220](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K892220.md) | LAMINARIA TENT | Berkeley Medevices | Jun 14, 1989 | SESE |
| [K881295](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K881295.md) | LAMINARIA CUREX | Harold W. Berger Co. | Aug 10, 1988 | SESE |
| [K881312](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K881312.md) | LAMINARIA | Busse Hospital Disposables, Inc. | May 23, 1988 | SESE |
| [K880196](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K880196.md) | LAMINARIA | Medgyn Products, Inc. | May 6, 1988 | SESE |
| [K845006](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K845006.md) | SUN MEDICAL LAMINARIA CERVICAL DILATOR | Sun Medical, Inc. | May 1, 1985 | SESE |
| [K833068](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K833068.md) | LAMINARIA JAPONICA CERVICAL DILATOR | Medi-Spec | Feb 4, 1984 | SESE |
| [K782067](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K782067.md) | DILATOR, MIZUTANI LAMINARIA TENT | British Marketing Ent., Ltd. | Jan 3, 1979 | SESE |

## Top Applicants

- A & A Medical, Inc. — 1 clearance
- Atad Developments , Ltd. — 1 clearance
- Berkeley Medevices — 1 clearance
- British Marketing Ent., Ltd. — 1 clearance
- Busse Hospital Disposables, Inc. — 1 clearance

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

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