FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CADDIE
K Number: K252586
·
Decision Sep 12, 2025
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
2
Review Days
28
Basic Information
- Device Name
- CADDIE
- K Number
- K252586
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Odin Medical Limited
- Date Received
- August 15, 2025
- Decision Date
- September 12, 2025
- Product Code
- QNP
- 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 |
|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Odin Medical Limited
| K Number | Device Name | ||
|---|---|---|---|
| K240044 | CADDIE | Jul 24, 2024 | Substantially Equivalent |