SB Knife Jr2 (MD-47702 and MD-47702L)— 510(k) K241855

Substantially Equivalent

Sb-Kawasumi Laboratories, Inc.

FDA 510(k) clearance K241855 for SB Knife Jr2 (MD-47702 and MD-47702L), Substantially Equivalent on 2025-03-26. Applicant: Sb-Kawasumi Laboratories, Inc..

Clearance details

Applicant: Sb-Kawasumi Laboratories, Inc.
Product code: 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

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.