Agile Esophageal Stent System
FDA 510(k) clearance K233837 · decided 2024-04-04
Clearance details
- K-number
- K233837
- Device name
- Agile Esophageal Stent System
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-12-04
- Decision date
- 2024-04-04
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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