AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System— 510(k) K181905
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K181905 for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System, Substantially Equivalent on 2019-03-25. 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 allMore 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 →
Recalls naming K181905
K-number listed on FDA's recall record- Z-1030-2025 — AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
- Z-1031-2025 — AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
- Z-0773-2021 — AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Z-0774-2021 — AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Z-0775-2021 — AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Z-0776-2021 — Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Z-0777-2021 — Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Z-0778-2021 — Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181905.
Data sourced from openFDA. This site is unofficial and independent of the FDA.