[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.1185]

[Page 421]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 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.

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