510(k) K233318 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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 Electrocaute
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | Sep 29, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;
Material Number (UPN): M00553660; Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;
Material Number (UPN): M00553680; Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;
Material Number (UPN): M00553690; Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm;
Material Number (UPN): M00553520; Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm;
Material Number (UPN): M00553530; Open, Classified |
KNS | None listed |
| Feb 5, 2026 | Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm;
Material Number (UPN): M00553560; Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553640 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553650 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553660 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553670 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553680 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553690 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553520 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553530 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553540 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553550 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553560 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553570 Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.