AUTOMATED ELECTROCAUTERY SYSTEM— 510(k) K812213

Substantially Equivalent

University of Washington

FDA 510(k) clearance K812213 for AUTOMATED ELECTROCAUTERY SYSTEM, Substantially Equivalent on 1981-11-05. Applicant: University of Washington.

Clearance details

Applicant: University of Washington
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1981-08-05
Decision date: 1981-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.