Endoflux Biliary and Pancreatic Stent Sets
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Biliary Stents & Sets EUDAMED
- Model / Reference
- GBS-01-11-008 EUDAMEDGBS-27-07-004S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052838002998 EUDAMED04052838015332 EUDAMED
- Basic UDI-DI
- B-04052838002998 EUDAMEDB-04052838015332 EUDAMED
- 510(k) Number
- K251658 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
- EMDN Code
- P0502 BILIARY AND PANCREATIC PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Endoflux Biliary and Pancreatic Stent Sets are classified as Stents, Drains and Dilators for the Biliary Ducts, per the OpenFDA nomenclature. These devices are designed to facilitate biliary and pancreatic duct drainage, stenting, and dilation in clinical procedures, supporting the management of obstructions or strictures in these anatomical regions.
The sets are intended for use in endoscopic or interventional radiology procedures, supplied sterile for single-use. They include a range of stent sizes and reference codes as listed in the regulatory submission (e.g., 1000117748, 3009121749). Authorized under the FDA 510(k) pathway as substantially equivalent, these devices comply with the Medical Device Directive (MDD) and are classified under device class II. Storage and handling must adhere to manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What types of procedures are the Endoflux Biliary & Pancreatic Stent Sets designed for, and how are they used in those settings?
The Endoflux Biliary & Pancreatic Stent Sets are specifically designed for endoscopic or interventional radiology procedures to facilitate drainage, stenting, and dilation of the biliary and pancreatic ducts. They are intended to manage obstructions or strictures in these anatomical regions, helping to restore patency and alleviate blockages.
Are the Endoflux Biliary & Pancreatic Stent Sets single-use or reusable, and how should they be handled to maintain sterility?
The Endoflux Biliary & Pancreatic Stent Sets are supplied sterile for single-use only. To maintain sterility and performance, they must be stored and handled according to the manufacturer’s guidelines, which likely include keeping the packaging intact until immediate use and avoiding contamination.
What range of stent sizes are available in the Endoflux Biliary & Pancreatic Stent Sets, and how are they identified?
The Endoflux Biliary & Pancreatic Stent Sets include a variety of stent sizes, each associated with a unique reference code (e.g., 1000117748, 3009121749). These codes help clinicians select the appropriate size for their patient’s anatomical needs, ensuring proper fit and functionality during biliary or pancreatic duct interventions.
How were the Endoflux Biliary & Pancreatic Stent Sets evaluated for regulatory approval, and what medical specialties are they relevant to?
The Endoflux Biliary & Pancreatic Stent Sets were evaluated through the FDA 510(k) pathway, determined to be substantially equivalent to a predicate device. They are classified under device class II and comply with the Medical Device Directive (MDD). These devices are relevant to gastroenterology and urology, as indicated by their regulatory submission and advisory committee classification.
What should clinicians consider when storing the Endoflux Biliary & Pancreatic Stent Sets to ensure they remain effective?
Since the Endoflux Biliary & Pancreatic Stent Sets are sterile and single-use, clinicians must store them in their original packaging to preserve sterility and integrity. The manufacturer’s guidelines should be followed strictly, including proper temperature and environmental conditions, to prevent degradation and ensure the devices remain ready for use when needed.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251658 | Class II | Active |
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Manufacturer
- Manufacturer
- Medi-Globe GmbH
Sources (3)
- FDA 510(k) K251658 24 fields · synced Sep 30, 2026
- EUDAMED cd7490ce-06c2-404e-a071-c928887e13a3 61 fields · synced Sep 17, 2026
- EUDAMED a8f5f0f2-44b4-4f1d-a117-ff0234d76286 61 fields · synced Sep 30, 2026