FDA 510(k)

AXIOS Stent and Electrocautery-Enhanced Delivery System

K-Number: K220112 · 2022-09-07

Decision Date2022-09-07

Product CodePCU

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AXIOS Stent and Electrocautery-Enhanced Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K220112. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOS Stent and Electrocautery-Enhanced Delivery System?

AXIOS Stent and Electrocautery-Enhanced Delivery System is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Boston Scientific Corporation. The 510(k) number is K220112.

When did AXIOS Stent and Electrocautery-Enhanced Delivery System receive FDA 510(k) clearance?

AXIOS Stent and Electrocautery-Enhanced Delivery System received FDA 510(k) clearance on 2022-09-07, under 510(k) number K220112.

Who is the listed applicant for AXIOS Stent and Electrocautery-Enhanced Delivery System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIOS Stent and Electrocautery-Enhanced Delivery System?

The FDA product code for AXIOS Stent and Electrocautery-Enhanced Delivery System is PCU.

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Related Devices (Code: PCU)

K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation

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.