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FDA 510(k)

BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER

K-Number: K892384 · 1989-05-04

ApplicantPorges Corp.
Decision Date1989-05-04
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Porges Corp.. It received FDA 510(k) clearance on 1989-05-04 under 510(k) number K892384. 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 BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER?

BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1989-05-04. The listed applicant is Porges Corp.. The 510(k) number is K892384.

When did BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER receive FDA 510(k) clearance?

BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER received FDA 510(k) clearance on 1989-05-04, under 510(k) number K892384.

Who is the listed applicant for BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER?

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

What is the FDA product code for BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER?

The FDA product code for BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER is FGE.

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Other records listing Porges Corp. as applicant

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K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEK900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERSK896503PORGES ERCP CATHETERSK896505PORGES UNIVERSAL HANDLESK896425PORGES CYTOLOGY BRUSHESK896507PORGES DIATHERMY SNARE

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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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