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FDA 510(k)

OncoPatch

K-Number: K252296 · 2025-12-05

ApplicantOncopatch, Inc.
Decision Date2025-12-05
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OncoPatch is a medical device manufactured by Oncopatch, Inc.. It received FDA 510(k) clearance on 2025-12-05 under approval number K252296. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OncoPatch?

OncoPatch is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Oncopatch, Inc.. The 510(k) number is K252296.

When was OncoPatch approved by the FDA?

OncoPatch received FDA 510(k) clearance on 2025-12-05, under approval number K252296.

What company makes OncoPatch?

OncoPatch is manufactured by Oncopatch, Inc..

What is the FDA product code for OncoPatch?

The FDA product code for OncoPatch is KXK.

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Official Source

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

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