FDA 510(k)

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

Número K: K160241 · 2016-03-02

Data da decisão2016-03-02

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K160241. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K160241.

When did Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 receive FDA 510(k) clearance?

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 received FDA 510(k) clearance on 2016-03-02, under 510(k) number K160241.

Who is the listed applicant for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

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

What is the FDA product code for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215?

The FDA product code for Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 is KNS.

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Outros registros que listam Olympus Medical Systems Corp. como candidato(a)

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Puxador Ativado na Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Puxador Ativado na Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Puxador Ativado na Frente S (TB-0520FCS)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)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

Ver todos os 80 dispositivos →

Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation 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

Fonte oficial

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