FDA 510(k)

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers

K-Number: K251291 · 2025-07-03

Decision Date2025-07-03

Product CodeFGE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2025-07-03 under approval number K251291. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers?

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Boston Scientific. The 510(k) number is K251291.

When was Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers approved by the FDA?

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers received FDA 510(k) clearance on 2025-07-03, under approval number K251291.

What company makes Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers?

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers is manufactured by Boston Scientific.

What is the FDA product code for Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers?

The FDA product code for Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers is FGE.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.