K892895

Substantially Equivalent

MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM

Applicant: Everest Medical Corp.
Product code: KNS
Advisory panel: Gastroenterology, Urology
Date received: 1989-04-25
Decision date: 1989-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Center, MN, US

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.