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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-09-04 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K201134.

When did Arthrex NanoScope System receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex NanoScope System?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arthrex NanoScope System?

The FDA product code for Arthrex NanoScope System is GCJ.

Related Clinical Trials

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NCT07553975Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional ArthroscopyNOT_YET_RECRUITING

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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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