SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long— 510(k) K152771

Substantially Equivalent

Sumitomo Bakelite Co., Ltd.

FDA 510(k) clearance K152771 for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long, Substantially Equivalent on 2016-06-17. Applicant: Sumitomo Bakelite Co., Ltd..

Clearance details

Applicant: Sumitomo Bakelite Co., Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2015-09-25
Decision date: 2016-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, 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.