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FDA 510(k)

IMAGE1 (TC400US); X-to-4U Adapter (TC040)

K-Number: K253972 · 2026-02-12

ApplicantKarl Storz SE & CO. KG
Decision Date2026-02-12
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMAGE1 (TC400US); X-to-4U Adapter (TC040) is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-02-12 under approval number K253972. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

IMAGE1 (TC400US); X-to-4U Adapter (TC040) is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K253972.

When was IMAGE1 (TC400US); X-to-4U Adapter (TC040) approved by the FDA?

IMAGE1 (TC400US); X-to-4U Adapter (TC040) received FDA 510(k) clearance on 2026-02-12, under approval number K253972.

What company makes IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

IMAGE1 (TC400US); X-to-4U Adapter (TC040) is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

The FDA product code for IMAGE1 (TC400US); X-to-4U Adapter (TC040) is OWN.

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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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