510(k) K201832— Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

Substantially Equivalent

Olympus Medical Systems Corp.

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2020-07-02
Decision date: 2021-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.