FDA 510(k)

CodMan Certas Plus Programmable Valve

K-Number: K182265 · 2018-11-20

Decision Date2018-11-20

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CodMan Certas Plus Programmable Valve is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K182265. 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 CodMan Certas Plus Programmable Valve?

CodMan Certas Plus Programmable Valve is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K182265.

When did CodMan Certas Plus Programmable Valve receive FDA 510(k) clearance?

CodMan Certas Plus Programmable Valve received FDA 510(k) clearance on 2018-11-20, under 510(k) number K182265.

Who is the listed applicant for CodMan Certas Plus Programmable Valve?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CodMan Certas Plus Programmable Valve?

The FDA product code for CodMan Certas Plus Programmable Valve 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.