FDA 510(k)

Stent Pancreático Biodegradável ARCHIMEDES

Número K: K243412 · 2025-07-16

RequerenteQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)

Data da decisão2025-07-16

Código do produtoFGE

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARCHIMEDES Biodegradable Pancreatic Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K243412. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARCHIMEDES Biodegradable Pancreatic Stent?

ARCHIMEDES Biodegradable Pancreatic Stent is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). The 510(k) number is K243412.

When did ARCHIMEDES Biodegradable Pancreatic Stent receive FDA 510(k) clearance?

ARCHIMEDES Biodegradable Pancreatic Stent received FDA 510(k) clearance on 2025-07-16, under 510(k) number K243412.

Who is the listed applicant for ARCHIMEDES Biodegradable Pancreatic Stent?

The FDA 510(k) record lists Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHIMEDES Biodegradable Pancreatic Stent?

The FDA product code for ARCHIMEDES Biodegradable Pancreatic Stent is FGE.

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Outros registros que listam Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) como candidato(a)

K260835ARCHIMEDES Biodegradable Stent (Medium)

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

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