21 CFR § 884.4260
Hygroscopic Laminaria cervical dilator
June 25, 2020
(a) 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.
(b) Classification. Class II (performance standards).