Cleared Traditional

Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)

K251664 · Olympus Medical Systems Corporation · Anesthesiology

Jul 2025

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K251664 is an FDA 510(k) clearance for the Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022), a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Olympus Medical Systems Corporation (Hachiochi-Shi, JP). The FDA issued a Cleared decision on July 29, 2025, 60 days after receiving the submission on May 30, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K251664 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	July 29, 2025
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).