21 C.F.R. § 884.4500
Obstetric fetal destructive instrument.
Cite as 21 C.F.R. § 884.4500 (2026)
(a)
Identification.
An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.
(b)
Classification.
Class II (performance standards).