Tao Brush I.U.M.C. Endometrial Sampler

• • Terminated Z-1416-2009 FDA Unclassified (pre-2012) ·initiated 2 Apr 2009

  There is an ink on the brush which has not been tested for use with the Tao Brush.

510(k) Number

K082066 ↗

FDA Product Code

HFE

Device Class

Class II

Regulation

21 CFR Part 884.1100

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cook Urological, Inc. →

• What is the Tao Brush I.U.M.C. Endometrial Sampler used for?

  The Tao Brush I.U.M.C. Endometrial Sampler is designed to obtain endometrial cytological and histological samples for use in obstetrics and gynecology procedures. It features a 9.0Fr/26 cm size with a 3.5 cm sampling area.

• How is the Tao Brush Endometrial Sampler supplied?

  The device is supplied as a Class 2 medical device with product code HFE. It is manufactured by Cook Urological, Inc. and is available in a single size configuration of 9.0Fr/26 cm with a 3.5 cm sampling area.

• What is the regulatory status of the Tao Brush Endometrial Sampler?

  The Tao Brush I.U.M.C. Endometrial Sampler has received FDA 510(k) clearance through the Traditional pathway on November 7, 2008. It is classified as a Class 2 medical device with product code HFE and was determined to be substantially equivalent.

• Is the Tao Brush Endometrial Sampler reusable or single-use?

  The device data does not specify whether the Tao Brush Endometrial Sampler is designed for single-use or reuse. For proper usage instructions and disposal information, please refer to the manufacturer's documentation or contact Cook Urological, Inc. directly.