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Accurette

by Axcan Scientific Corp. 510(k)

Active United States

510(k) K820641

Overview

An endometrial aspirator is a device used to collect tissue samples from the uterine lining for diagnostic evaluation. The Accurette is an endometrial aspirator designed for the collection of endometrial tissue specimens.

It is supplied as a single-use, non-sterile device intended for use in clinical settings such as outpatient gynecology offices. The device is not MRI safe and should be stored according to manufacturer instructions. Authorization is based on FDA 510(k) clearance K820641, granted on June 22, 1982, under product code HFF and regulation number 884.1060.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820641 Date22 Jun 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HFF
Device Class
Class II
Regulation
21 CFR Part 884.1060
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Axcan Scientific Corp.

Questions

  • What is the Accurette endometrial aspirator used for?

    The Accurette is designed to collect tissue samples from the uterine lining for diagnostic evaluation, specifically endometrial tissue specimens in clinical settings such as outpatient gynecology offices.

  • Is the Accurette device sterile or non-sterile, and is it intended for single use or reuse?

    The Accurette is supplied as a single-use, non-sterile device, meaning it is not sterilized before use and is intended for one-time use only in clinical settings to prevent cross-contamination.

  • What regulatory authorization does the Accurette have, and when was it cleared?

    The Accurette received FDA 510(k) clearance under number K820641 on June 22, 1982, based on substantial equivalence to a legally marketed predicate device under product code HFF and regulation 884.1060.