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FDA 510(k)

Single Use Aspiration Needle

K-Number: K190239 · 2019-12-10

ApplicantOlympus Medical Systems Corp.
Decision Date2019-12-10
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Aspiration Needle is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-12-10 under approval number K190239. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Aspiration Needle?

Single Use Aspiration Needle is a medical device that received FDA 510(k) clearance on 2019-12-10. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K190239.

When was Single Use Aspiration Needle approved by the FDA?

Single Use Aspiration Needle received FDA 510(k) clearance on 2019-12-10, under approval number K190239.

What company makes Single Use Aspiration Needle?

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

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

The FDA product code for Single Use Aspiration Needle is KTI.

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: KTI)

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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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