21 CFR 884.4260 — Dilator, Cervical, Hygroscopic-Laminaria

Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4260

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).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HDYDilator, Cervical, Hygroscopic-Laminaria2113rd Party
PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor223rd Party
PKNDilator, Cervical, Synthetic, Osmotic213rd Party
PONCatheter, Balloon, Dilation Of Cervical Canal243rd Party
Innolitics

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