K161112

Substantially Equivalent

KARL STORZ Flexible Video-Neuro-Endoscope System

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: GWG
Advisory panel: Neurology
Date received: 2016-04-20
Decision date: 2016-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.