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FDA 510(k)

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

K-Number: K243409 · 2024-11-27

Decision Date2024-11-27
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-11-27 under approval number K243409. The device is classified under product code FBO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K243409.

When was KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) approved by the FDA?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) received FDA 510(k) clearance on 2024-11-27, under approval number K243409.

What company makes KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

The FDA product code for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is FBO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.