[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: 21CFR884.1060]

[Page 420]
 
                        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. 884.1060  Endometrial aspirator.

    (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.

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