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FDA 510(k)

KARL STORZ HOPKINS Telescopes for Urology

K-Number: K243653 · 2025-08-13

ApplicantKarl Storz SE & CO. KG
Decision Date2025-08-13
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ HOPKINS Telescopes for Urology is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-08-13 under approval number K243653. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ HOPKINS Telescopes for Urology?

KARL STORZ HOPKINS Telescopes for Urology is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K243653.

When was KARL STORZ HOPKINS Telescopes for Urology approved by the FDA?

KARL STORZ HOPKINS Telescopes for Urology received FDA 510(k) clearance on 2025-08-13, under approval number K243653.

What company makes KARL STORZ HOPKINS Telescopes for Urology?

KARL STORZ HOPKINS Telescopes for Urology is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ HOPKINS Telescopes for Urology?

The FDA product code for KARL STORZ HOPKINS Telescopes for Urology is FAJ.

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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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