eCFR Reference Browser

---

title: "21 CFR §884.5100"

source: "https://www.ecfr.gov/current/title-21/section-884.5100"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "884"

part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"

subpart_code: "F"

subpart_subject: "Obstetrical and Gynecological Therapeutic Devices"

section_number: "884.5100"

section_subject: "Obstetric anesthesia set."

cfr_reference: "21 CFR 884.5100"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§884.5100 - Obstetric anesthesia set.