Endobrush(Tm) Device; Omnibrush

FDA 510(k) K897070 · Intl. Cytobrush, Inc.

Substantially Equivalent

510(k) numberK897070

Submission

Device name
Endobrush(Tm) Device; Omnibrush
Applicant
Intl. Cytobrush, Inc.
Hollywood, FL, US
Received
December 22, 1989
Decision date
September 10, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HFE – Brush, Endometrial
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1100
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFE

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K240595Utepreva Endometrial Sampler (UP01)HFE · Traditional Utepreva, LLC08/14/2024SE
K170603Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional Cook Incorporated05/24/2017SE
K112763Matrixbrush Endometrial SamplerHFE · Traditional Post Oak Innovations, Inc.06/18/2012SE
K082066Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional Cook Urological, Inc.11/07/2008SE
K941298Iumc Endometrial SamplerHFE · Traditional Cook Ob/Gyn02/13/1995SE
K911620Stovall Endometrial BrushHFE · Traditional Cook Ob/Gyn06/24/1994SE
K881220Endocyte, Disposable Endometrial SamplerHFE · Traditional Laboratoire Ccd C/O Washington Regulatory Services06/14/1988SE
K843941EndocyteHFE · Traditional Gyneco, Inc.02/25/1985SE

More from Gyneco, Inc.

510(k)DeviceDecision
K895675Pap Smear TrayHHT · Traditional 12/11/1989SE
K862322Chlamydia Kit, STD KitHHT · Traditional 07/07/1986SE
K861389Pap Smear KitHHT · Traditional 05/02/1986SE

Questions and answers

When was Endobrush(Tm) Device; Omnibrush cleared by the FDA?

Endobrush(Tm) Device; Omnibrush (K897070) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 262 days after the submission was received.

What is the product code of K897070?

The FDA product code is HFE – Brush, Endometrial, a Class II (moderate risk) device regulated under 21 CFR 884.1100.