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FDA 510(k)

INTEGRA ELECTRODE TUNNELING NEEDLE

K-Number: K102802 · 2010-11-23

ApplicantIntegra LifeSciences Corporation
Decision Date2010-11-23
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTEGRA ELECTRODE TUNNELING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K102802. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA ELECTRODE TUNNELING NEEDLE?

INTEGRA ELECTRODE TUNNELING NEEDLE is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K102802.

When did INTEGRA ELECTRODE TUNNELING NEEDLE receive FDA 510(k) clearance?

INTEGRA ELECTRODE TUNNELING NEEDLE received FDA 510(k) clearance on 2010-11-23, under 510(k) number K102802.

Who is the listed applicant for INTEGRA ELECTRODE TUNNELING NEEDLE?

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

What is the FDA product code for INTEGRA ELECTRODE TUNNELING NEEDLE?

The FDA product code for INTEGRA ELECTRODE TUNNELING NEEDLE is GYC.

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Official Source

View on FDA Database →

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

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