VAGINAL SPECULUM
Device Facts
| Record ID | K890376 |
|---|---|
| Device Name | VAGINAL SPECULUM |
| Applicant | Kinetic Medical Products |
| Product Code | HFD · Obstetrics/Gynecology |
| Decision Date | Feb 27, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1185 |
| Device Class | Class 2 |
Regulatory Classification
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).
Special Controls
*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.
