Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)— 510(k) K252646

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K252646 for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H), Substantially Equivalent on 2025-10-24. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-21
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.