K241855

Substantially Equivalent

SB Knife Jr2 (MD-47702 and MD-47702L)

Applicant: Sb-Kawasumi Laboratories, Inc.
Product code: KNS
Advisory panel: Gastroenterology, Urology
Date received: 2024-06-27
Decision date: 2025-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kawasaki-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.