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FDA 510(k)

Single Use Aspiration Needle NA-U401SX

K-Number: K160098 · 2016-03-22

ApplicantOlympus Medical Systems Corp.
Decision Date2016-03-22
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Aspiration Needle NA-U401SX is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-03-22 under approval number K160098. 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?

Single Use Aspiration Needle NA-U401SX is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K160098.

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

Single Use Aspiration Needle NA-U401SX received FDA 510(k) clearance on 2016-03-22, under approval number K160098.

What company makes Single Use Aspiration Needle NA-U401SX?

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

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

The FDA product code for Single Use Aspiration Needle NA-U401SX 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 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 K172734Single Use Electrosurgical Snare SD-400

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Related Devices (Code: FCG)

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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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