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FDA 510(k)

INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS

K-Number: K924387 · 1995-09-08

ApplicantInstent, Inc.
Decision Date1995-09-08
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Instent, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K924387. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS?

INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Instent, Inc.. The 510(k) number is K924387.

When did INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS receive FDA 510(k) clearance?

INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS received FDA 510(k) clearance on 1995-09-08, under 510(k) number K924387.

Who is the listed applicant for INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS?

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

What is the FDA product code for INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS?

The FDA product code for INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS is FGE.

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Other records listing Instent, 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.

K955041INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEMK945498INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESISK941487INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS

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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