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510(k) K021672

Device
PANCREATIC DRAINAGE TUBE
Applicant
AOMORI OLYMPUS CO., LTD.
510(k) number
K021672
Product code
FGE  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-16
Date received
2002-05-21
Regulation
876.5010
Classification name
Stents, Drains And Dilators For The Biliary Ducts
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
2 Corporate Center Dr. Melville NY US 11747 11747

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254179Drainage CatheterCanyon Medical, Inc.2026-09-18
K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.2026-09-17
K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2026-07-27
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.2026-06-24
K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.2026-04-24
K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH2026-04-16
K253987BARE Wireguided Balloon Dilation Catheter (1235)GIE Medical2026-03-13
K253132Single use stone retrieval balloonsZhejiang Chuangxiang Medical Technology Co., Ltd.2026-03-06
K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd.2025-12-29
K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation2025-12-22
K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)Olympus Medical Systems Corporation2025-10-21
K251229EndoFix™Tissue Fixation SystemSoftac Medical Technologies2025-08-20
K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2025-07-16
K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and PushersBoston Scientific2025-07-03
K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc.2025-06-25

Legacy Summary#

summary

FDA Review#

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