Flexible Overtube— 510(k) K182520

Substantially Equivalent

Sumitomo Bakelite Co., Ltd.

FDA 510(k) clearance K182520 for Flexible Overtube, Substantially Equivalent on 2019-05-15. Applicant: Sumitomo Bakelite Co., Ltd..

Clearance details

Applicant: Sumitomo Bakelite Co., Ltd.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-13
Decision date: 2019-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shinagawa-Ku, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.