Arthrex NanoScope System
K-Number: K190645 · 2019-07-05
ApplicantArthrex, Inc.
Decision Date2019-07-05
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 2019-07-05 under approval number K190645. 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 2019-07-05. It is manufactured by Arthrex, Inc.. The 510(k) number is K190645.
When was Arthrex NanoScope System approved by the FDA?
Arthrex NanoScope System received FDA 510(k) clearance on 2019-07-05, under approval number K190645.
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.
Related Clinical Trials
Other Devices by Arthrex, Inc.
Related Devices (Code: GCJ)
K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien
K160801Well Lead Extraction BagWell Lead Medical Co., Ltd.
K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp.
K161720Standard ClampStandard Bariatrics
K162445LiVac Retractor SystemLivac Pty, Ltd.
K162584VersaOne Bladeless TrocarCovidien
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.