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FDA 510(k)

Miniature Telescope for Urology (27033AA)

K-Number: K253411 · 2025-11-18

ApplicantKarl Storz SE & CO. KG
Decision Date2025-11-18
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Miniature Telescope for Urology (27033AA) is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-11-18 under approval number K253411. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miniature Telescope for Urology (27033AA)?

Miniature Telescope for Urology (27033AA) is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K253411.

When was Miniature Telescope for Urology (27033AA) approved by the FDA?

Miniature Telescope for Urology (27033AA) received FDA 510(k) clearance on 2025-11-18, under approval number K253411.

What company makes Miniature Telescope for Urology (27033AA)?

Miniature Telescope for Urology (27033AA) is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for Miniature Telescope for Urology (27033AA)?

The FDA product code for Miniature Telescope for Urology (27033AA) is FGB.

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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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