FDA.reportPublic FDA data

Archimedes Biodegradable Pancreatic Stent

Primary DI
00850078427182
Brand
Archimedes Biodegradable Pancreatic Stent
Company
Q3 Medical USA LLC
Model
BPS26080FUS
Catalog number
BPS26080FUS
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
00850078427182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078427182008500784271828500784271820850078427182

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
00850078427250ARCHIMEDES Biodegradable StentBPS20040MUSBPS20040MUS2026-09-18
00850078427267ARCHIMEDES Biodegradable StentBPS20060MUSBPS20040MUS2026-09-18
00850078427274ARCHIMEDES Biodegradable StentBPS20080MUSBPS20080MUS2026-09-18
00850078427281ARCHIMEDES Biodegradable StentBPS20100MUSBPS20100MUS2026-09-18
00850078427298ARCHIMEDES Biodegradable StentBPS20125MUSBPS20125MUS2026-09-18
00850078427304ARCHIMEDES Biodegradable StentBPS20150MUSBPS20150MUS2026-09-18
00850078427311ARCHIMEDES Biodegradable StentBPS20175MUSBPS20175MUS2026-09-18
00850078427328ARCHIMEDES Biodegradable StentBPS34040MUSBPS34040MUS2026-09-18
00850078427335ARCHIMEDES Biodegradable StentBPS34060MUSBPS34060MUS2026-09-18
00850078427342ARCHIMEDES Biodegradable StentBPS34080MUSBPS34080MUS2026-09-18
00850078427359ARCHIMEDES Biodegradable StentBPS34100MUSBPS34100MUS2026-09-18
00850078427366ARCHIMEDES Biodegradable StentBPS34125MUSBPS34125MUS2026-09-18
00850078427373ARCHIMEDES Biodegradable StentBPS34150MUSBPS34150MUS2026-09-18
00850078427380ARCHIMEDES Biodegradable StentBPS34175MUSBPS34175MUS2026-09-18
00850078427397ARCHIMEDES Biodegradable StentBPS34200MUSBPS34200MUS2026-09-18
00850078427403ARCHIMEDES Biodegradable StentBPS34225MUSBPS34225MUS2026-09-18
00850078427410ARCHIMEDES Biodegradable StentBPS26040MUSBPS26040MUS2026-09-18
00850078427427ARCHIMEDES Biodegradable StentBPS26060MUSBPS26060MUS2026-09-18
00850078427434ARCHIMEDES Biodegradable StentBPS26080MUSBPS26080MUS2026-09-18
00850078427441ARCHIMEDES Biodegradable StentBPS26100MUSBPS26100MUS2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27