eCFR Reference Browser

---

title: "21 CFR §884.4340"

source: "https://www.ecfr.gov/current/title-21/section-884.4340"

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: "E"

subpart_subject: "Obstetrical and Gynecological Surgical Devices"

section_number: "884.4340"

section_subject: "Fetal vacuum extractor."

cfr_reference: "21 CFR 884.4340"

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. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

(b)Classification. Class II (performance standards).

§884.4340 - Fetal vacuum extractor.