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

Clearance details

Applicant

Sumitomo Bakelite Co., Ltd.

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

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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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 →