21 CFR 884.1060
§ 884.1060 Endometrial aspirator.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 884.1060, § 884.1060 Endometrial aspirator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90779
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.