FDA 510(k)

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

Numéro K : K252889 · 2025-11-25

DemandeurOlympus Medical Systems Corporation

Date de décision2025-11-25

Code produitKNS

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Olympus Medical Systems Corporation en tant que demandeur

K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K260856Disposable Distal Attachment D-201-13404 K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Dispositifs connexes (Code : KNS)

K262460Rezum SystemBoston Scientific 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

Source officielle

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