Scopis Extended Instrument Set EM— 510(k) K171661

Substantially Equivalent

Scopis GmbH

FDA 510(k) clearance K171661 for Scopis Extended Instrument Set EM, Substantially Equivalent on 2017-09-27. Applicant: Scopis GmbH.

Clearance details

Applicant: Scopis GmbH
Product code: Code PGW
Advisory panel: Neurology
Date received: 2017-06-05
Decision date: 2017-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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.