21 CFR § 884.5100
Obstetric anesthesia set
June 25, 2020
(a) Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
(b) Classification. Class II (performance standards).