21 CFR 884.1185 — Washer, Endometrial
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1185
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).
Classification Rationale
Class II. The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HFD | Washer, Endometrial | 2 | 3 | 3rd Party |
Special Controls
HFD — Washer, Endometrial
*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.
eCFR
HFD — Washer, Endometrial
(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.
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