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FDA 510(k)

R STENT BILIARY ENDOPROSTHESIS

K-Number: K010107 · 2001-07-31

ApplicantOrbus Medical Technologies
Decision Date2001-07-31
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

R STENT BILIARY ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Orbus Medical Technologies. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K010107. 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 R STENT BILIARY ENDOPROSTHESIS?

R STENT BILIARY ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Orbus Medical Technologies. The 510(k) number is K010107.

When did R STENT BILIARY ENDOPROSTHESIS receive FDA 510(k) clearance?

R STENT BILIARY ENDOPROSTHESIS received FDA 510(k) clearance on 2001-07-31, under 510(k) number K010107.

Who is the listed applicant for R STENT BILIARY ENDOPROSTHESIS?

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

What is the FDA product code for R STENT BILIARY ENDOPROSTHESIS?

The FDA product code for R STENT BILIARY ENDOPROSTHESIS is FGE.

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Other records listing Orbus Medical Technologies 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.

K041370LIFESTENT LP SDS BILIARY ENDOPROSTHESISK041032MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESISK040550LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESISK033212LIFESTENT SDS BILIARY ENDOPROSTHESISK023308LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESISK023121LIFESTENT BILIARY ENDOPROSTHESIS

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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