Pap Brush

FDA 510(k) K963801 · Young OU Brush Co.

Substantially Equivalent

510(k) numberK963801

Submission

Device name
Pap Brush
Applicant
Young OU Brush Co.
Kyong Buk, KR
Received
September 23, 1996
Decision date
April 9, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HHT – Spatula, Cervical, Cytological
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHT

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K182049exCellerator Cervical Collection DeviceHHT · Traditional Excell Company, LLC04/25/2019SE
K153128Kolplast Cervical Sample Collection KitHHT · Traditional Kolplast CI SA01/13/2017SE
K141057Disposable Cervical BrushHHT · Traditional Ningbo Hls Medical Products Co., Ltd.05/14/2015SE
K111681HistobrushHHT · Traditional Puritan Medical Products Company, LLC01/19/2012SE
K083012PapconeHHT · Traditional Otto Bock Pur Life Science GmbH04/09/2009SE
K081522Bio Nuclear Diagnostics (Endo)Cervical Sampler for Gyn CytologyHHT · Traditional Bio Nuclear Diagnostics, Inc.12/05/2008SE
K072381Softpap Cervical Cell CollectorHHT · Special Cytocore, Inc.01/30/2008SE
K062433Diamics Cercol Cervical Sample Collector SystemHHT · Traditional Diamics, Inc.03/16/2007SE
K043369Cervex-Brush CombiHHT · Traditional Rovers Medical Devices B.V.02/02/2005SE
K042527Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional Medical Action Industries, Inc.11/08/2004SE

Questions and answers

When was Pap Brush cleared by the FDA?

Pap Brush (K963801) received a 510(k) decision of Substantially Equivalent on April 9, 1997, 198 days after the submission was received.

What is the product code of K963801?

The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.