SB Soft Hood - Straight type, SB Soft Hood - Undercut type— 510(k) K173004

Substantially Equivalent

Sumitomo Bakelite Co., Ltd.

FDA 510(k) clearance K173004 for SB Soft Hood - Straight type, SB Soft Hood - Undercut type, Substantially Equivalent on 2018-05-08. Applicant: Sumitomo Bakelite Co., Ltd..

Clearance details

Applicant: Sumitomo Bakelite Co., Ltd.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-27
Decision date: 2018-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shinagawa-Ku, JP

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Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.