FDA 510(k)

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

K-Number: K252889 · 2025-11-25

ApplicantOlympus Medical Systems Corporation

Decision Date2025-11-25

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) 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 2025-11-25 under 510(k) number K252889. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K252889.

When did Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) receive FDA 510(k) clearance?

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252889.

Who is the listed applicant for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

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 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?

The FDA product code for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is KNS.

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Other records listing Olympus Medical Systems Corporation as applicant

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-LB K260580Single 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

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Related Devices (Code: KNS)

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical K251226Aqua Medical RF Vapor Ablation SystemAqua 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.