FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
K Number: DEN230019
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
231
Review Days
144
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Basic Information
- Device Name
- AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
- K Number
- DEN230019
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5016
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Boston Scientific Corporation
- Date Received
- March 27, 2023
- Decision Date
- August 18, 2023
- Product Code
- QXH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QXH | Gallbladder Drainage Stent And Delivery System | FDA class 2 | Gastroenterology, Urology |
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