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FDA 510(k)

Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)

K-Number: K262552 · 2026-08-14

ApplicantScivita Medical Technology Co., Ltd.
Decision Date2026-08-14
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K262552. 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 Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)?

Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K262552.

When did Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) receive FDA 510(k) clearance?

Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K262552.

Who is the listed applicant for Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)?

The FDA 510(k) record lists Scivita Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)?

The FDA product code for Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) is FGB.

Related Clinical Trials

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.

NCT07630155Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial CarcinomaRECRUITING

Other records listing Scivita Medical Technology Co., Ltd. as applicant

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.

K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)K240192Single-use Extraction BasketsK231521Broncho Videoscope System

View all 13 devices →

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.

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.K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine 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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