FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SugarBug (1.x)
K Number: K250264
·
Decision Nov 7, 2025
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
36
Applicant Total
1
Review Days
282
Basic Information
- Device Name
- SugarBug (1.x)
- K Number
- K250264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2070
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bench7, Inc.
- Date Received
- January 29, 2025
- Decision Date
- November 7, 2025
- Product Code
- MYN
- 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 |
|---|---|---|---|
| MYN | Analyzer, Medical Image | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MYN), ordered by most recent decision date.
Velmeni for Dentists (V4D) Endo-Perio
FDA 510(k)
FDA Class 2
·Radiology
qXR-Detect
FDA 510(k)
FDA Class 2
·Radiology
Diagnocat
FDA 510(k)
FDA Class 2
·Radiology
DS Core Detect
FDA 510(k)
FDA Class 2
·Radiology
DTX Studio Assist
FDA 510(k)
FDA Class 2
·Radiology
Second Opinion® Panoramic
FDA 510(k)
FDA Class 2
·Radiology