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FDA 510(k)

KARL STORZ Trocars with Valve Seals

K-Number: K254228 · 2026-05-11

ApplicantKarl Storz SE & CO. KG
Decision Date2026-05-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Trocars with Valve Seals 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 2026-05-11 under 510(k) number K254228. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Trocars with Valve Seals?

KARL STORZ Trocars with Valve Seals is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K254228.

When did KARL STORZ Trocars with Valve Seals receive FDA 510(k) clearance?

KARL STORZ Trocars with Valve Seals received FDA 510(k) clearance on 2026-05-11, under 510(k) number K254228.

Who is the listed applicant for KARL STORZ Trocars with Valve Seals?

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 KARL STORZ Trocars with Valve Seals?

The FDA product code for KARL STORZ Trocars with Valve Seals is GCJ.

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

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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