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FDA 510(k)

WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY

K-Number: K914277 · 1991-11-29

ApplicantSchneider U.S. Stent Div.
Decision Date1991-11-29
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY is the device name listed in this FDA 510(k) record. The listed applicant is Schneider U.S. Stent Div.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K914277. 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 WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY?

WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Schneider U.S. Stent Div.. The 510(k) number is K914277.

When did WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY receive FDA 510(k) clearance?

WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY received FDA 510(k) clearance on 1991-11-29, under 510(k) number K914277.

Who is the listed applicant for WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY?

The FDA 510(k) record lists Schneider U.S. Stent Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY?

The FDA product code for WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY is FGE.

Related Clinical Trials

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.

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Other records listing Schneider U.S. Stent Div. 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.

K923993WALLSTENT BILIARY ENDOPROTHESESK923119WALLSTENT ESOPHAGEAL PROTHESIS

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

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