Contour-Flex Valve and Shunt System

FDA 510(k) K033698 · Integra Neurosciences Implants S.A.

Substantially Equivalent

510(k) numberK033698

Submission

Device name
Contour-Flex Valve and Shunt System
Applicant
Integra Neurosciences Implants S.A.
Planisboro, NJ, US
Received
November 25, 2003
Decision date
December 17, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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Questions and answers

When was Contour-Flex Valve and Shunt System cleared by the FDA?

Contour-Flex Valve and Shunt System (K033698) received a 510(k) decision of Substantially Equivalent on December 17, 2003, 22 days after the submission was received.

What is the product code of K033698?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.