FDA.reportPublic FDA data

Archimedes Biodegradable Pancreatic Stent

Primary DI
00850078427021
Brand
Archimedes Biodegradable Pancreatic Stent
Company
Q3 Medical USA LLC
Model
BPS20080FUS
Catalog number
BPS20080FUS
Device description
The ARCHIMEDESTM Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.
Published
2025-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243412000ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2025-07-16FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078427021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078427021008500784270218500784270210850078427021

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric biliary/pancreatic stentA sterile bioabsorbable tubular device intended to be implanted in an obstructed/stenosed biliary and pancreatic duct (i.e., a dual-purpose device capable of implantation at either anatomy) to temporarily maintain luminal patency. It is in the form of a non-expandable tube (not mesh-like) which may include retention barbs at each end, and is made of a synthetic polymer(s) [e.g., polydioxanone, polyurethane] which will gradually disintegrate(s) following implantation; it may be radiopaque (e.g., include barium sulfate). Disposable devices intended to assist implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep in a cool, dark and dry place.
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117150469
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078427007Archimedes Biodegradable Pancreatic StentBPS20040FUSBPS20040FUS2025-11-25
00850078427014Archimedes Biodegradable Pancreatic StentBPS20060FUSBPS20060FUS2025-11-25
00850078427038Archimedes Biodegradable Pancreatic StentBPS20100FUSBPS20100FUS2025-11-25
00850078427045Archimedes Biodegradable Pancreatic StentBPS20125FUSBPS20125FUS2025-11-25
00850078427052Archimedes Biodegradable Pancreatic StentBPS20150FUSBPS20150FUS2025-11-25
00850078427069Archimedes Biodegradable Pancreatic StentBPS20175FUSBPS20175FUS2025-11-25
00850078427076Archimedes Biodegradable Pancreatic StentBPS34040FUSBPS34040FUS2025-11-25
00850078427083Archimedes Biodegradable Pancreatic StentBPS34060FUSBPS34060FUS2025-11-25
00850078427090Archimedes Biodegradable Pancreatic StentBPS34080FUSBPS34080FUS2025-11-25
00850078427106Archimedes Biodegradable Pancreatic StentBPS34100FUSBPS34100FUS2025-11-25
00850078427113Archimedes Biodegradable Pancreatic StentBPS34125FUSBPS34125FUS2025-11-25
00850078427120Archimedes Biodegradable Pancreatic StentBPS34150FUSBPS34150FUS2025-11-25
00850078427137Archimedes Biodegradable Pancreatic StentBPS34175FUSBPS34175FUS2025-11-25
00850078427144Archimedes Biodegradable Pancreatic StentBPS34200FUSBPS34200FUS2025-11-25
00850078427151Archimedes Biodegradable Pancreatic StentBPS34225FUSBPS34225FUS2025-11-25
00850078427168Archimedes Biodegradable Pancreatic StentBPS26040FUSBPS26040FUS2025-11-25
00850078427175Archimedes Biodegradable Pancreatic StentBPS26060FUSBPS26060FUS2025-11-25
00850078427182Archimedes Biodegradable Pancreatic StentBPS26080FUSBPS26080FUS2025-11-25
00850078427199Archimedes Biodegradable Pancreatic StentBPS26100FUSBPS26100FUS2025-11-25
00850078427205Archimedes Biodegradable Pancreatic StentBPS26125FUSBPS26125FUS2025-11-25

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Primary DI, Brand, Company table
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08714729793328MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
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