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FDA 510(k)

Arthrex NanoScope System

K-Number: K201134 · 2020-09-04

ApplicantArthrex, Inc.
Decision Date2020-09-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Arthrex NanoScope System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-09-04 under approval number K201134. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex NanoScope System?

Arthrex NanoScope System is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Arthrex, Inc.. The 510(k) number is K201134.

When was Arthrex NanoScope System approved by the FDA?

Arthrex NanoScope System received FDA 510(k) clearance on 2020-09-04, under approval number K201134.

What company makes Arthrex NanoScope System?

Arthrex NanoScope System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex NanoScope System?

The FDA product code for Arthrex NanoScope System is GCJ.

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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.