AXIOS Stent and Electrocautery Enhanced Delivery System— 510(k) K203132
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K203132 for AXIOS Stent and Electrocautery Enhanced Delivery System, Substantially Equivalent on 2021-04-15. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code PCU
- Device class
- Class 2
- Regulation
- 21 CFR 876.5015
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code PCU
view all- K252648 — Niti-S SPAXUS Stent
- K220112 — AXIOS Stent and Electrocautery-Enhanced Delivery System
- K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K181905 — AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
- K163272 — AXIOS Stent and Electrocautery Enhanced Delivery System
More clearances from Boston Scientific Corporation
view allAdverse events under product code PCU
product code PCU- Death
- 47
- Injury
- 804
- Malfunction
- 709
- Total
- 1,560
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.