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FDA 510(k)

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)

K-Number: K243550 · 2025-06-06

ApplicantKarl Storz SE & CO. KG
Decision Date2025-06-06
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-06-06 under approval number K243550. 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 KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K243550.

When was KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) approved by the FDA?

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) received FDA 510(k) clearance on 2025-06-06, under approval number K243550.

What company makes KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

The FDA product code for KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is FGB.

Related Clinical Trials

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Related Devices (Code: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

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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