§ 884.1185. Endometrial washer.

164 words·~1 min read·/us/cfr/t21/s§ 884.1185·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)Identification. An endometrial washer is a device used to remove materials from the endometrium (the mucosal lining of the uterus) by washing with water or saline solution and then aspirating with negative pressure. 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 Organization for Standardization's 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,

(ii)Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and

(iii)Warning: Do not attach to a wall or any external suction, and

(3)Design and Testing:

(i)The sampling component is covered within the vagina, and

(ii)Intrauterine pressure should not exceed 50 millimeters of mercury. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]

Connections1 cite this

Cited by 1 section

Rules and Regulations
Final rule

Citation graph

cites case law

§ 884.1185

Endometrial washer.

Fed. Reg.×1

Cites 0Cited by 1 across 1 source