← Product Code [HDY](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY) · K011512

# MMODIFICATION TO LAMINARIA (K011512)

_A & A Medical, Inc. · HDY · Jul 9, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K011512

## Device Facts

- **Applicant:** A & A Medical, Inc.
- **Product Code:** [HDY](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY.md)
- **Decision Date:** Jul 9, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4260
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K011512](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K011512)

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