Atlas FDA

AXIOS Stent and Electrocautery-Enhanced Delivery System

FDA 510(k) clearance K220112 · decided 2022-09-07

Clearance details

K-number
K220112
Device name
AXIOS Stent and Electrocautery-Enhanced Delivery System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2022-01-13
Decision date
2022-09-07
Days to decision
237 days
Clearance type
Traditional
Product code
PCU
Device class
2
Regulation number
876.5015
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Niti-S SPAXUS Stent (K252648)Taewoong Medical Co., Ltd.2026-03-13
AXIOS Stent and Electrocautery Enhanced Delivery System (K203132)Boston Scientific Corporation2021-04-15
AXIOS Stent and Electrocautery Enhanced Delivery System (K192043)Boston Scientific Corporation2019-08-26
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (K181905)Boston Scientific Corporation2019-03-25
AXIOS Stent and Electrocautery Enhanced Delivery System (K163272)Boston Scientific Corporation2017-02-18
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (K153088)Boston Scientific Corporation2015-12-11
AXIOS Stent and Delivery System (K152572)Boston Scientific Corporation2015-10-06
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) (K140561)Xlumena, Inc.2014-04-23
AXIOS STENT AND DELIVERY SYSTEM (DEN130007)Xlumena, Inc.2013-12-18

Recalls involving this device

No recalls on record reference this clearance.

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