§ 884.1060. Endometrial aspirator.

131 words·~1 min read·/us/cfr/t21/s§ 884.1060·

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(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]

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§ 884.1060

Endometrial aspirator.

Fed. Reg.×1

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