§884.1060. Endometrial aspirator.
21 C.F.R. § 884.1060
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).
Classification. Class II. The special controls for this device are:
FDA's—
“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
“510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
Labeling—
Indication— Only to evaluate the endometrium, and
Contraindications— Pregnancy, history of uterine perforation, or a recent cesarean section, and
The sampling component is covered within vagina.
Notes, amendments, and revision history
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]