510(k) K201135— Image1 S CCU, Image1 S 4U Camera Head

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2020-04-28
Decision date: 2020-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.