K250351

Substantially Equivalent

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

Applicant: Olympus Medical Systems Corporation
Product code: KNS
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-07
Decision date: 2025-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

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.