TIPCAM 1S 3D System— 510(k) K162880

Substantially Equivalent

Karl Storz Endoscopy America, Inc.

FDA 510(k) clearance K162880 for TIPCAM 1S 3D System, Substantially Equivalent on 2017-03-16. Applicant: Karl Storz Endoscopy America, Inc..

Clearance details

Applicant: Karl Storz Endoscopy America, Inc.
Product code: Code GWG
Advisory panel: Neurology
Date received: 2016-10-14
Decision date: 2017-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

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.