K091968

Substantially Equivalent

KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: FCW
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-01
Decision date: 2009-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.