CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES > SUBPART B—Obstetrical and Gynecological Diagnostic Devices (§884.1040 to §884.1730) > 884.1185—Endometrial washer.

884.1185—Endometrial washer.

(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.

Code of Federal Regulations

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]