K063585

Substantially Equivalent

KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: FDF
Advisory panel: Gastroenterology, Urology
Date received: 2006-12-01
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.