Deep Capsule® (Deep Capsule US)
by Digestaid - Artificial Intelligence Development SA 510(k)
Active
510(k) K250655
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250655 | Date12 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 10 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QZF
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent