FDA.reportPublic FDA data

510(k) K241888

Device
Single-use Balloon Dilatation Catheter
Applicant
Leo Medical Co., Ltd.
510(k) number
K241888
Product code
FGE
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-20
Date received
2024-06-28
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
Guojun Zhang
Address
#10 Bldg., 23 Middle Huashan Rd., Xinbei District Changzhou CN 213022 213022

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
K241801Tornus ESAsahi Intecc Co., Ltd.2024-12-17
K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific2024-12-06
K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMVBoston Scientific2024-08-30