Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1060](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1060) → HFF — Aspirator, Endometrial

# HFF · Aspirator, Endometrial

_Obstetrics/Gynecology · 21 CFR 884.1060 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF

## Overview

- **Product Code:** HFF
- **Device Name:** Aspirator, Endometrial
- **Regulation:** [21 CFR 884.1060](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1060)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **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](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF/K041237.md) | ECHOSAMPLER | Gynetics Medical Products NV | Sep 8, 2004 | SESE |
| [K903002](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF/K903002.md) | PROBET (TM) | Gynopharma, Inc. | Apr 5, 1991 | SESE |
| [K902693](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF/K902693.md) | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER | Wallach Surgical Devices, Inc. | Jan 31, 1991 | SESE |
| [K831212](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF/K831212.md) | ENDOSCANN | Axcan Scientific Corp. | Jun 15, 1984 | SESE |
| [K820641](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF/K820641.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFF)

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