HFF · Aspirator, Endometrial
Obstetrics/Gynecology · 21 CFR 884.1060 · Class 2
Overview
| Product Code | HFF |
|---|---|
| Device Name | Aspirator, Endometrial |
| Regulation | 21 CFR 884.1060 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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).
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 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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041237 | ECHOSAMPLER | Gynetics Medical Products NV | Sep 8, 2004 | SESE |
| K903002 | PROBET (TM) | Gynopharma, Inc. | Apr 5, 1991 | SESE |
| K902693 | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER | Wallach Surgical Devices, Inc. | Jan 31, 1991 | SESE |
| K831212 | ENDOSCANN | Axcan Scientific Corp. | Jun 15, 1984 | SESE |
| K820641 | ACCURETTE | Axcan Scientific Corp. | Jun 22, 1982 | SESE |
Top Applicants
- Axcan Scientific Corp. — 2 clearances
- Gynetics Medical Products NV — 1 clearance
- Gynopharma, Inc. — 1 clearance
- Wallach Surgical Devices, Inc. — 1 clearance
