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FDA 510(k)

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

K-Number: K244001 · 2025-05-02

ApplicantKarl Storz SE & CO. KG
Decision Date2025-05-02
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-05-02 under approval number K244001. 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 Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)?

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K244001.

When was KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) approved by the FDA?

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) received FDA 510(k) clearance on 2025-05-02, under approval number K244001.

What company makes KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)?

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)?

The FDA product code for KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) is FBO.

Other Devices by Karl Storz SE & CO. KG

K180735Endomat Select K201355Endomat Select, IBS Shaver Software, License K192090CMOS Video Rhino-Laryngoscope SSU K192523CMOS Video Esophagoscope SSU K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit K232857KARL STORZ ICG Imaging System

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Related Devices (Code: FBO)

K243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KG

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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