510(k) clearance
CADDIE
- 510(k) number
- K260133
- Applicant
- Odin Medical Limited
- Decision date
- Sep 12, 2026
- Date received
- Jan 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QNP
- Device type
- Gastrointesinal Lesion Software Detection System
- Device class
- Class II
- Regulation
- 21 CFR 876.1520
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- London, GB