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FDA 510(k)

BARE Wireguided Balloon Dilation Catheter (1235)

N.º K: K253987 · 2026-03-13

SolicitanteGIE Medical
Fecha de decisión2026-03-13
Código de productoFGE
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

BARE Wireguided Balloon Dilation Catheter (1235) is the device name listed in this FDA 510(k) record. The listed applicant is GIE Medical. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K253987. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BARE Wireguided Balloon Dilation Catheter (1235)?

BARE Wireguided Balloon Dilation Catheter (1235) is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is GIE Medical. The 510(k) number is K253987.

When did BARE Wireguided Balloon Dilation Catheter (1235) receive FDA 510(k) clearance?

BARE Wireguided Balloon Dilation Catheter (1235) received FDA 510(k) clearance on 2026-03-13, under 510(k) number K253987.

Who is the listed applicant for BARE Wireguided Balloon Dilation Catheter (1235)?

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

What is the FDA product code for BARE Wireguided Balloon Dilation Catheter (1235)?

The FDA product code for BARE Wireguided Balloon Dilation Catheter (1235) is FGE.

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Dispositivos relacionados (Código: FGE)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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