Arthrex NanoScope System

Laparoscope, General & Plastic Surgery

Arthrex, Inc.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Nanoscope System.

Pre-market Notification Details

Device IDK201134
510k NumberK201134
Device Name:Arthrex NanoScope System
ClassificationLaparoscope, General & Plastic Surgery
Applicant Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactHeli F Chambi Infantas
CorrespondentHeli F Chambi Infantas
Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-28
Decision Date2020-09-04

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