SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long— 510(k) K190621

Substantially Equivalent

Sumitomo Bakelite Co., Ltd.

FDA 510(k) clearance K190621 for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long, Substantially Equivalent on 2019-04-23. Applicant: Sumitomo Bakelite Co., Ltd..

Clearance details

Applicant: Sumitomo Bakelite Co., Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-11
Decision date: 2019-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shinagawa-Ku, JP

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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.