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FDA 510(k)

WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

K-Number: K914881 · 1992-01-07

ApplicantWiltek Medical, Inc.
Decision Date1992-01-07
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1992-01-07 under 510(k) number K914881. 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 WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER?

WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER is a medical device that received FDA 510(k) clearance on 1992-01-07. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K914881.

When did WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER receive FDA 510(k) clearance?

WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER received FDA 510(k) clearance on 1992-01-07, under 510(k) number K914881.

Who is the listed applicant for WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER?

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

What is the FDA product code for WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER?

The FDA product code for WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER is FGE.

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Other records listing Wiltek Medical, 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.

K990231WILTEK HOT BIOPSY FORCEPSK922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTORK914132WILTEK ELECTROCAUTERY ACTIVE CORD

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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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