Amielle

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K983045 ↗

FDA Product Code

KXP

Device Class

Class II

Regulation

21 CFR Part 884.3900

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Autoject 2 Open recall

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  FDA 510(k) K973899 Active Cleared 4 Dec 1997

• Rapport V.T.D.

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  FDA 510(k) K971443 Active Cleared 26 Sep 1997

• Owen Mumford 3ml Autopen

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  FDA 510(k) K983974 Active Cleared 21 Dec 1998

• Autoject Mini

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  FDA 510(k) K953735 Active Cleared 8 Nov 1995

• Unifine

  Class II

  FDA 510(k) K983994 Active Cleared 8 Jan 1999

See all devices from Owen Mumford USA, Inc. →

• What is the Amielle device used for?

  The Amielle device is a vaginal stent designed to treat women suffering from vaginismus and dyspareunia, which involve involuntary vaginal muscle spasms and painful intercourse, by helping to reduce muscle tension and improve comfort during intercourse.

• Is the Amielle device sterile or non-sterile when supplied?

  The Amielle device is provided non-sterile, as stated in the device data, and is intended for repeated use after appropriate cleaning by the user or as directed by a healthcare provider.

• Can the Amielle device be reused, and how often is it typically used?

  Yes, the Amielle device is reusable and intended for repeated application, typically for five to ten minutes, three to four times per week, as directed by a healthcare provider, based on the device's intended use for home application.