Cervex-Brush Combi

FDA 510(k) K043369 · Rovers Medical Devices B.V.

Substantially Equivalent

510(k) numberK043369

Submission

Device name
Cervex-Brush Combi
Applicant
Rovers Medical Devices B.V.
Oss, NL
Received
December 8, 2004
Decision date
February 2, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

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K042527Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional Medical Action Industries, Inc.11/08/2004SE
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More from Doctor'S Research Group, Inc.

510(k)DeviceDecision
K002520Rovers SpatulaHHT · Abbreviated 11/13/2000SE
K001119Rovers Endocervex-BrushHHT · Abbreviated 05/19/2000SE

Questions and answers

When was Cervex-Brush Combi cleared by the FDA?

Cervex-Brush Combi (K043369) received a 510(k) decision of Substantially Equivalent on February 2, 2005, 56 days after the submission was received.

What is the product code of K043369?

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