FDA.report

510(k) K243412

Device
ARCHIMEDES Biodegradable Pancreatic Stent
Applicant
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
510(k) number
K243412
Product code
FGE
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-16
Date received
2024-11-01
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Eric Mangiardi
Address
1800 Camden Rd., Suite 107 Charlotte NC US 28203 28203

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850078427120Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427007Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427014Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427021Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427038Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427045Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427052Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427069Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427076Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427083Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427090Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427106Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427113Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427243Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427137Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427144Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427151Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427168Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427175Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427182Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427199Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427205Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427212Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427229Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25
00850078427236Archimedes Biodegradable Pancreatic StentQ3 Medical USA LLC2025-11-25

Other 510(k) Records For Product Code FGE

510(k)DeviceApplicantDecision date
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
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
K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)Cook Ireland, Ltd.2024-06-14