K233318

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)

510(k) number: K233318
Device name: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
Applicant: Boston Scientific Corporation MA · US
Product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
Decision date: 2023-10-27
Date received: 2023-09-29
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain

Also available from FDA: K233318.pdf

Official FDA record: K233318

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.