Wallach Flexible Endometrial Sampler

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

510(k) Number

K902693 ↗

FDA Product Code

HFF

Device Class

Class II

Regulation

21 CFR Part 884.1060

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• Wallach Cc/Brush

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  FDA 510(k) K896065 Active Cleared 4 Jan 1990

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  FDA 510(k) K871681 Active Cleared 5 Aug 1987

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See all devices from Wallach Surgical Devices, Inc. →

• What is the Wallach Flexible Endometrial Sampler used for?

  The Wallach Flexible Endometrial Sampler is an aspirator device specifically designed for obtaining endometrial tissue samples during obstetrics and gynecology procedures. It helps clinicians collect tissue samples for diagnostic purposes.

• How is the Wallach Flexible Endometrial Sampler supplied?

  The Wallach Flexible Endometrial Sampler is supplied as a Class II medical device with FDA 510K clearance under product code HFF. It is manufactured by Wallach Surgical Devices, Inc. and is available in various sizes as indicated by multiple model numbers.

• Is the Wallach Flexible Endometrial Sampler reusable or single-use?

  The device data does not specify whether the Wallach Flexible Endometrial Sampler is designed for single-use or reuse. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal procedures for this device.

• What regulatory status does the Wallach Flexible Endometrial Sampler have?

  The Wallach Flexible Endometrial Sampler has FDA 510K clearance under product code HFF with a decision code of SESE (Substantially Equivalent). It was received by the FDA on June 19, 1990, and cleared on January 31, 1991.