FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Accuro® 3S Needle Guide Kit
K Number: K250469
·
Decision Jun 13, 2025
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
3
Review Days
115
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Basic Information
- Device Name
- Accuro® 3S Needle Guide Kit
- K Number
- K250469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rivanna Medical, Inc.
- Date Received
- February 18, 2025
- Decision Date
- June 13, 2025
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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