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FDA 510(k)

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

K-Number: K251664 · 2025-07-29

ApplicantOlympus Medical Systems Corporation
Decision Date2025-07-29
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-07-29 under 510(k) number K251664. 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 (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)?

Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251664.

When did Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) receive FDA 510(k) clearance?

Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) received FDA 510(k) clearance on 2025-07-29, under 510(k) number K251664.

Who is the listed applicant for Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)?

The FDA product code for Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) is KTI.

Other records listing Olympus Medical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 112 devices →

Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K250263Disposable Grasping Forceps FG-52D/FG-54DOlympus Medical Systems Corp.

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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