Deep Capsule® (Deep Capsule US)— 510(k) K250655

Name: FDA 510(k) clearance K250655
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Digestaid - Artificial Intelligence Development SA

FDA 510(k) clearance K250655 for Deep Capsule® (Deep Capsule US), Substantially Equivalent on 2026-03-12. Applicant: Digestaid - Artificial Intelligence Development SA. Device class: 2.

Clearance details

Applicant: Digestaid - Artificial Intelligence Development SA
Product code: Code QZF
Device class: Class 2
Regulation: 21 CFR 876.1540
Advisory panel: Gastroenterology, Urology
Date received: 2025-03-05
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gondomar, PT

Download summary PDF View on FDA.gov ↗

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