21 CFR § 884.5100 Obstetrical and Gynecological Devices

§ 884.5100 Obstetric anesthesia set.

Current through Sep 8, 2026 · Read all of Part 884

(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).

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