21 C.F.R. § 884.4260
Hygroscopic Laminaria cervical dilator.
Cite as 21 C.F.R. § 884.4260 (2026)
(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).