K160241

Substantially Equivalent

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

Applicant: Olympus Medical Systems Corp.
Product code: KNS
Advisory panel: Gastroenterology, Urology
Date received: 2016-02-01
Decision date: 2016-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Hachioji-Shi, JP

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.