Section 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, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000