FDA 510(k)

HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM

K-Number: K122118 · 2012-08-03

Decision Date2012-08-03

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2012-08-03 under 510(k) number K122118. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM?

HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-03. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K122118.

When did HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM receive FDA 510(k) clearance?

HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM received FDA 510(k) clearance on 2012-08-03, under 510(k) number K122118.

Who is the listed applicant for HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM?

The FDA product code for HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM is JXG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.