Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)— 510(k) K251664

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K251664 for Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022), Substantially Equivalent on 2025-07-29. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 2025-05-30
Decision date: 2025-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.