eCFR Reference Browser

---

title: "21 CFR §884.1060"

source: "https://www.ecfr.gov/current/title-21/section-884.1060"

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: "B"

subpart_subject: "Obstetrical and Gynecological Diagnostic Devices"

section_number: "884.1060"

section_subject: "Endometrial aspirator."

cfr_reference: "21 CFR 884.1060"

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 endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).

(b)Classification. Class II. The special controls for this device are:

(1)FDA's:

(i)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and

(ii)“510(k) Sterility Review Guidance of 2/12/90 (K90-1),”

(2)Labeling:

(i)Indication: Only to evaluate the endometrium, and

(ii)Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and

(3)The sampling component is covered within vagina.

§884.1060 - Endometrial aspirator.