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FDA 510(k)

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

K-Number: K180668 · 2018-11-15

ApplicantOlympus Medical Systems Corp.
Decision Date2018-11-15
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2018-11-15 under approval number K180668. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N?

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K180668.

When was Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N approved by the FDA?

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N received FDA 510(k) clearance on 2018-11-15, under approval number K180668.

What company makes Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N?

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N?

The FDA product code for Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N is FCG.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

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Related Devices (Code: FCG)

K160423Perineologic Access NeedleCorbin Clinical Resources, LLC K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp. K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland, Ltd. K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd. K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleWilson-Cook Medical, Inc. K160890Howell Biliary Introducer NeedleWilson-Cook Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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