FDA 510(k)

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

N.º K: K251123 · 2025-12-29

Fecha de decisión2025-12-29

Código de productoFGE

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K251123. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Niti-S Biliary Stent; Niti-S Biliary Slim M Stent?

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K251123.

When did Niti-S Biliary Stent; Niti-S Biliary Slim M Stent receive FDA 510(k) clearance?

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent received FDA 510(k) clearance on 2025-12-29, under 510(k) number K251123.

Who is the listed applicant for Niti-S Biliary Stent; Niti-S Biliary Slim M Stent?

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

What is the FDA product code for Niti-S Biliary Stent; Niti-S Biliary Slim M Stent?

The FDA product code for Niti-S Biliary Stent; Niti-S Biliary Slim M Stent is FGE.

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Otros registros que enlistan a Taewoong Medical Co., Ltd. como solicitante

K260962Sphincterotome K252648Niti-S SPAXUS Stent K243619Niti-S Esophageal Stent; Esophageal TTS Stent K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent K223626Niti-S Biliary Speed D Stent

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Dispositivos relacionados (Código: FGE)

K254179Drainage CatheterCanyon Medical, Inc.K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)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-5251-128019Hangzhou AGS MedTech Co., Ltd.K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH

Fuente oficial

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