PENTAX Medical Video Upper GI Scopes EG17-J10— 510(k) K210177

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K210177 for PENTAX Medical Video Upper GI Scopes EG17-J10, Substantially Equivalent on 2021-10-20. Applicant: Pentax of America, Inc..

Clearance details

Applicant: Pentax of America, Inc.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2021-01-22
Decision date: 2021-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

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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.