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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 the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-06-06 under 510(k) 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. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K243550.

When did KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) receive FDA 510(k) clearance?

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

Who is the listed applicant for KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Karl Storz SE & CO. KG as applicant

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Related Devices (Code: FGB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.

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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