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FDA 510(k)

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX

K-Number: K102519 · 2010-11-22

ApplicantFlexible Stenting Solutions, Inc.
Decision Date2010-11-22
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX is the device name listed in this FDA 510(k) record. The listed applicant is Flexible Stenting Solutions, Inc.. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K102519. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX?

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Flexible Stenting Solutions, Inc.. The 510(k) number is K102519.

When did FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX receive FDA 510(k) clearance?

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX received FDA 510(k) clearance on 2010-11-22, under 510(k) number K102519.

Who is the listed applicant for FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX?

The FDA 510(k) record lists Flexible Stenting Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX?

The FDA product code for FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX is FGE.

Related Clinical Trials

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Other records listing Flexible Stenting Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121125FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMK120452FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMK112522FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMK081996FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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