eCFR Reference Browser

---

title: "21 CFR §884.1185"

source: "https://www.ecfr.gov/current/title-21/section-884.1185"

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: "884.1185"

section_subject: "Endometrial washer."

cfr_reference: "21 CFR 884.1185"

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 washer is a device used to remove materials from the endometrium (the mucosal lining of the uterus) by washing with water or saline solution and then aspirating with negative pressure. 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 Organization for Standardization's 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,

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

(iii)Warning: Do not attach to a wall or any external suction, and

(3)Design and Testing:

(i)The sampling component is covered within the vagina, and

(ii)Intrauterine pressure should not exceed 50 millimeters of mercury.

§884.1185 - Endometrial washer.