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FDA 510(k)

CODMAN Integrated Bipolar Cord and Tubing Set

K-Number: K163106 · 2016-12-01

ApplicantMedos International SARL
Decision Date2016-12-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CODMAN Integrated Bipolar Cord and Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K163106. 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 Integrated Bipolar Cord and Tubing Set?

CODMAN Integrated Bipolar Cord and Tubing Set is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Medos International SARL. The 510(k) number is K163106.

When did CODMAN Integrated Bipolar Cord and Tubing Set receive FDA 510(k) clearance?

CODMAN Integrated Bipolar Cord and Tubing Set received FDA 510(k) clearance on 2016-12-01, under 510(k) number K163106.

Who is the listed applicant for CODMAN Integrated Bipolar Cord and Tubing Set?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODMAN Integrated Bipolar Cord and Tubing Set?

The FDA product code for CODMAN Integrated Bipolar Cord and Tubing Set is GEI.

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Related Devices (Code: GEI)

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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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