HFD · Washer, Endometrial
Obstetrics/Gynecology · 21 CFR 884.1185 · Class 2
Overview
| Product Code | HFD |
|---|---|
| Device Name | Washer, Endometrial |
| Regulation | 21 CFR 884.1185 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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:
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891037 | WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE |
| K890376 | VAGINAL SPECULUM | Kinetic Medical Products | Feb 27, 1989 | SESE |
| K810558 | SKIN SCRUB TRAY | Associated Medical Products Co. | Mar 17, 1981 | SESE |
Top Applicants
- Associated Medical Products Co. — 1 clearance
- Kinetic Medical Products — 1 clearance
- Zinnanti Surgical Instruments, Inc. — 1 clearance
