KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM— 510(k) K122096

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K122096 for KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM, Substantially Equivalent on 2012-09-27. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2012-07-16
Decision date: 2012-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.