FDA.reportPublic FDA data

510(k) K223592

Device
Advanix? Pancreatic Stent and NaviFlex? Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Applicant
Boston Scientific Corporation
510(k) number
K223592
Product code
FGE
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-29
Date received
2022-12-01
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kerri LaPlaca
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

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
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
K241888Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd.2024-12-20
K241801Tornus ESAsahi Intecc Co., Ltd.2024-12-17
K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific2024-12-06