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Washer, Endometrial

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.1185
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.1185 Endometrial washer

§ 884.1185 Endometrial washer.

(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]

Washer, Endometrial

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.1185
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.1185 Endometrial washer

§ 884.1185 Endometrial washer.

(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]