Cytobrush

FDA 510(k) K890706 · Laboratoire Ccd C/O Washington Regulatory Services

Substantially Equivalent

510(k) numberK890706

Submission

Device name
Cytobrush
Applicant
Laboratoire Ccd C/O Washington Regulatory Services
Ringoes, NJ, US
Received
February 10, 1989
Decision date
April 25, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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

More from Medical Action Industries, Inc.

510(k)DeviceDecision
K884696Resubmitted Artificial Insemination Instrument SetHDR · Traditional 01/27/1989SE
K881456Pipelle de Cornier Endometrial Suction CuretteHHK · Traditional 10/14/1988SE
K881220Endocyte, Disposable Endometrial SamplerHFE · Traditional 06/14/1988SE

Questions and answers

When was Cytobrush cleared by the FDA?

Cytobrush (K890706) received a 510(k) decision of Substantially Equivalent on April 25, 1989, 74 days after the submission was received.

What is the product code of K890706?

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