Codman Hakim Programmable Valve W/Wo Siphonguard

Q: What is the product code of K053107?

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

FDA 510(k) K053107 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK053107

Submission

Device name: Codman Hakim Programmable Valve W/Wo Siphonguard
Applicant: Codman & Shurtleff, Inc.
Raynham, MA, US
Received: November 4, 2005
Decision date: January 19, 2006
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 Codman Hakim Programmable Valve W/Wo Siphonguard cleared by the FDA?

Codman Hakim Programmable Valve W/Wo Siphonguard (K053107) received a 510(k) decision of Substantially Equivalent on January 19, 2006, 76 days after the submission was received.

What is the product code of K053107?

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