CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR884.1060]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES

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