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FDA 510(k)

CADDIE

K-Number: K252586 · 2025-09-12

ApplicantOdin Medical Limited
Decision Date2025-09-12
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CADDIE is a medical device manufactured by Odin Medical Limited. It received FDA 510(k) clearance on 2025-09-12 under approval number K252586. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADDIE?

CADDIE is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Odin Medical Limited. The 510(k) number is K252586.

When was CADDIE approved by the FDA?

CADDIE received FDA 510(k) clearance on 2025-09-12, under approval number K252586.

What company makes CADDIE?

CADDIE is manufactured by Odin Medical Limited.

What is the FDA product code for CADDIE?

The FDA product code for CADDIE is QNP.

Other Devices by Odin Medical Limited

K240044CADDIE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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