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FDA 510(k)

Arthrex Synergy RF System

K-Number: K161581 · 2016-09-09

ApplicantArthrex, Inc.
Decision Date2016-09-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Arthrex Synergy RF System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-09-09 under approval number K161581. 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 Arthrex Synergy RF System?

Arthrex Synergy RF System is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Arthrex, Inc.. The 510(k) number is K161581.

When was Arthrex Synergy RF System approved by the FDA?

Arthrex Synergy RF System received FDA 510(k) clearance on 2016-09-09, under approval number K161581.

What company makes Arthrex Synergy RF System?

Arthrex Synergy RF System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Synergy RF System?

The FDA product code for Arthrex Synergy RF System is GEI.

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Official Source

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