ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018— 510(k) K021266

Substantially Equivalent

Ethicon Endo-Surgery, Inc.

FDA 510(k) clearance K021266 for ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018, Substantially Equivalent on 2002-09-27. Applicant: Ethicon Endo-Surgery, Inc..

Clearance details

Applicant: Ethicon Endo-Surgery, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-22
Decision date: 2002-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.