FDA.report

Archimedes Biodegradable Pancreatic Stent

Primary DI
00850078427199
Brand
Archimedes Biodegradable Pancreatic Stent
Company
Q3 Medical USA LLC
Model
BPS26100FUS
Catalog number
BPS26100FUS
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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications

CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K243412000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850078427199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078427199008500784271998500784271990850078427199

GMDN Terms

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

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

Sterilization Methods

Method

Regulatory Flags

DUNS number
117150469
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850078427007Archimedes Biodegradable Pancreatic StentBPS20040FUSBPS20040FUS2025-11-25
00850078427014Archimedes Biodegradable Pancreatic StentBPS20060FUSBPS20060FUS2025-11-25
00850078427021Archimedes Biodegradable Pancreatic StentBPS20080FUSBPS20080FUS2025-11-25
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
00850078427205Archimedes Biodegradable Pancreatic StentBPS26125FUSBPS26125FUS2025-11-25

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