FDA 510(k)

Sphincterotome

N.º K: K222421 · 2023-05-03

SolicitanteHangzhou AGS MedTech Co., Ltd.

Fecha de decisión2023-05-03

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-03 under 510(k) number K222421. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sphincterotome?

Sphincterotome is a medical device that received FDA 510(k) clearance on 2023-05-03. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K222421.

When did Sphincterotome receive FDA 510(k) clearance?

Sphincterotome received FDA 510(k) clearance on 2023-05-03, under 510(k) number K222421.

Who is the listed applicant for Sphincterotome?

The FDA 510(k) record lists Hangzhou AGS MedTech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sphincterotome?

The FDA product code for Sphincterotome is KNS.

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Otros registros que enlistan a Hangzhou AGS MedTech Co., Ltd. como solicitante

K254069Hemoclip (511 series, 543 series)K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 K252270Hemoclip K252271Hemoclip K241704Endoscopic Water Pump K221713Polypectomy Snare

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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

Fuente oficial

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