FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
K Number: K252703
·
Decision Sep 24, 2025
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
112
Applicant Total
231
Review Days
28
Basic Information
- Device Name
- LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
- K Number
- K252703
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- August 27, 2025
- Decision Date
- September 24, 2025
- Product Code
- FGB
- 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 |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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