eCFR Reference Browser

---

title: "21 CFR §884.5070"

source: "https://www.ecfr.gov/current/title-21/section-884.5070"

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: "884.5070"

section_subject: "Vacuum abortion system."

cfr_reference: "21 CFR 884.5070"

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 vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

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

§884.5070 - Vacuum abortion system.