4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA— 510(k) K172817

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K172817 for 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA, Substantially Equivalent on 2017-10-17. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-18
Decision date: 2017-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.