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FDA 510(k)

Scopis Hybrid Navigation System EM

K-Number: K161491 · 2017-02-09

ApplicantScopis GmbH
Decision Date2017-02-09
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Scopis Hybrid Navigation System EM is a medical device manufactured by Scopis GmbH. It received FDA 510(k) clearance on 2017-02-09 under approval number K161491. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scopis Hybrid Navigation System EM?

Scopis Hybrid Navigation System EM is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Scopis GmbH. The 510(k) number is K161491.

When was Scopis Hybrid Navigation System EM approved by the FDA?

Scopis Hybrid Navigation System EM received FDA 510(k) clearance on 2017-02-09, under approval number K161491.

What company makes Scopis Hybrid Navigation System EM?

Scopis Hybrid Navigation System EM is manufactured by Scopis GmbH.

What is the FDA product code for Scopis Hybrid Navigation System EM?

The FDA product code for Scopis Hybrid Navigation System EM is PGW.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Scopis GmbH

K171661Scopis Extended Instrument Set EM

Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.

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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