PROBET (TM)
Device Facts
| Record ID | K903002 |
|---|---|
| Device Name | PROBET (TM) |
| Applicant | Gynopharma, Inc. |
| Product Code | HFF · Obstetrics/Gynecology |
| Decision Date | Apr 5, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1060 |
| Device Class | Class 2 |
Regulatory Classification
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).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard 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, and (ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and (3) The sampling component is covered within vagina.
