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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 the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-02-12 under 510(k) 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. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K253972.

When did IMAGE1 (TC400US); X-to-4U Adapter (TC040) receive FDA 510(k) clearance?

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

Who is the listed applicant for IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Karl Storz SE & CO. KG as applicant

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Related Devices (Code: 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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