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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 the device name listed in this FDA 510(k) record. The listed applicant is Scopis GmbH. It received FDA 510(k) clearance on 2017-02-09 under 510(k) 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. The listed applicant is Scopis GmbH. The 510(k) number is K161491.

When did Scopis Hybrid Navigation System EM receive FDA 510(k) clearance?

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

Who is the listed applicant for Scopis Hybrid Navigation System EM?

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

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

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

Other records listing Scopis GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171661Scopis Extended Instrument Set EM

Related Devices (Code: PGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, 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.

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