TGS Guidewire and updated Scopis Software— 510(k) K193118

Name: FDA 510(k) clearance K193118
Creator: U.S. Food and Drug Administration
Published: 2020-02-21

Substantially Equivalent

Stryker Ent

FDA 510(k) clearance K193118 for TGS Guidewire and updated Scopis Software, Substantially Equivalent on 2020-02-21. Applicant: Stryker Ent. Device class: 2.

Clearance details

Applicant: Stryker Ent
Product code: Code PGW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2019-11-12
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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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.