K092309

Substantially Equivalent

SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L

Applicant: Olympus Medical Systems Corporation
Product code: KNS
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-30
Decision date: 2009-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, 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.