FDA.reportPublic FDA data

510(k) K230127

Device
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K230127
Product code
FGE
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-06
Date received
2023-01-17
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
Sally He
Address
# 10 Gaoke Third Rd., Nanjing National Hi-Tech, Industrial Development Zone Nanjing CN 210032 210032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FGE#

510(k), Device, Applicant table
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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
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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
K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMVBoston Scientific2024-08-30