Boston Scientific · Class II · Cleared Jul 3, 2025
| K-number | K251291 |
| Device name | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers |
| Applicant | Boston Scientific |
| Product code | FGE |
| Device class | Class II |
| Decision date | Jul 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.5010 |
The Advanix™ Pancreatic Stent and NaviFlex™ RX Pancreatic Delivery System and Pushers is a plastic pancreatic stent designed for delivery to the pancreatic duct to drain pancreatic ducts. The stents are available in straight or single pigtail shapes with various features including trailing barbs, leading barbs, lateral drainage holes, tapered or rounded tips, and endoscopic or fluoroscopic markers depending on the specific configuration.
The proposed device is identical to the predicate's design, intended use, fundamental technology, operating principle, manufacturing process, and all materials. Both the proposed device and predicate (K223592) are pancreatic stents available in 4F and 5F sizes with the same feature variations including barb configurations, pigtail shapes, drainage holes, and marker options.
Not stated in this summary. The document lists specific test types performed (corrosion testing, tensile testing, lumen patency testing, biocompatibility testing including cytotoxicity and genotoxicity) but does not cite ISO, IEC, ASTM, or other consensus standards by number or name.
The device is substantially equivalent because it has identical design, intended use, fundamental technology, operating principle, manufacturing process, and materials to the predicate device K223592. Non-clinical testing demonstrates the proposed device is safe and effective for its intended use of pancreatic duct drainage, with performance data showing substantial equivalence to the predicate device.
View the full FDA submission: accessdata.fda.gov