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FDA 510(k)

Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable

K-Number: K182801 · 2018-11-27

ApplicantIntegra LifeSciences Corporation
Decision Date2018-11-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable 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 2018-11-27 under 510(k) number K182801. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable?

Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable is a medical device that received FDA 510(k) clearance on 2018-11-27. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K182801.

When did Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable receive FDA 510(k) clearance?

Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182801.

Who is the listed applicant for Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable?

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 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable?

The FDA product code for Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable is GEI.

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Official Source

View on FDA Database →

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