CADDIE— 510(k) K252586

Substantially Equivalent

Odin Medical Limited

FDA 510(k) clearance K252586 for CADDIE, Substantially Equivalent on 2025-09-12. Applicant: Odin Medical Limited. Device class: 2.

Clearance details

Applicant: Odin Medical Limited
Product code: Code QNP
Device class: Class 2
Regulation: 21 CFR 876.1520
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-15
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: London, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Odin Medical Limited

K240044 — CADDIE2024-07-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.