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FDA 510(k)

F88 URE-SD/RD Flexible Ureteroscope

K-Number: K243894 · 2025-05-02

ApplicantSg Endoscopy Pte, Ltd.
Decision Date2025-05-02
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

F88 URE-SD/RD Flexible Ureteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Sg Endoscopy Pte, Ltd.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K243894. 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 F88 URE-SD/RD Flexible Ureteroscope?

F88 URE-SD/RD Flexible Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Sg Endoscopy Pte, Ltd.. The 510(k) number is K243894.

When did F88 URE-SD/RD Flexible Ureteroscope receive FDA 510(k) clearance?

F88 URE-SD/RD Flexible Ureteroscope received FDA 510(k) clearance on 2025-05-02, under 510(k) number K243894.

Who is the listed applicant for F88 URE-SD/RD Flexible Ureteroscope?

The FDA 510(k) record lists Sg Endoscopy Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F88 URE-SD/RD Flexible Ureteroscope?

The FDA product code for F88 URE-SD/RD Flexible Ureteroscope is FGB.

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

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

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