Scopis Hybrid Navigation System EM— 510(k) K161491

Name: FDA 510(k) clearance K161491
Creator: U.S. Food and Drug Administration
Published: 2017-02-09

Substantially Equivalent

Scopis GmbH

FDA 510(k) clearance K161491 for Scopis Hybrid Navigation System EM, Substantially Equivalent on 2017-02-09. Applicant: Scopis GmbH. Device class: 2.

Clearance details

Applicant: Scopis GmbH
Product code: Code PGW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2016-06-01
Decision date: 2017-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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K262235 — ApexCut Blade with Automated EM Tracking (6 models)2026-09-04
K261540 — Cube 4D Navigation System, VirtuEye Pro2026-06-02
K253395 — Stealth AXiS ENT clinical application2026-03-16
K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC)2025-06-20
K231862 — TruDi® Navigation System V3 (FG-2000-00)2023-07-21

More clearances from Scopis GmbH

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K171661 — Scopis Extended Instrument Set EM2017-09-27

Adverse events under product code PGW

product code PGW

Malfunction: 1,199
Total: 1,199

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.