Deep Capsule® (Deep Capsule US)
FDA 510(k) clearance K250655 · decided 2026-03-12
Clearance details
- K-number
- K250655
- Device name
- Deep Capsule® (Deep Capsule US)
- Applicant
- Digestaid - Artificial Intelligence Development SA
- Decision
- Substantially Equivalent
- Date received
- 2025-03-05
- Decision date
- 2026-03-12
- Days to decision
- 372 days
- Clearance type
- Traditional
- Product code
- QZF
- Device class
- 2
- Regulation number
- 876.1540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gondomar, PT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.