FDA 510(k)

Scopis Extended Instrument Set EM

K-Number: K171661 · 2017-09-27

Decision Date2017-09-27

Product CodePGW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Scopis Extended Instrument Set EM is a medical device manufactured by Scopis GmbH. It received FDA 510(k) clearance on 2017-09-27 under approval number K171661. 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 Extended Instrument Set EM?

Scopis Extended Instrument Set EM is a medical device that received FDA 510(k) clearance on 2017-09-27. It is manufactured by Scopis GmbH. The 510(k) number is K171661.

When was Scopis Extended Instrument Set EM approved by the FDA?

Scopis Extended Instrument Set EM received FDA 510(k) clearance on 2017-09-27, under approval number K171661.

What company makes Scopis Extended Instrument Set EM?

Scopis Extended Instrument Set EM is manufactured by Scopis GmbH.

What is the FDA product code for Scopis Extended Instrument Set EM?

The FDA product code for Scopis Extended Instrument Set EM is PGW.

Other Devices by Scopis GmbH

K161491Scopis Hybrid Navigation System 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.