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FDA 510(k)

Uretero1 Ureteroscope System

K-Number: K211347 · 2021-11-23

ApplicantSTERIS Corporation
Decision Date2021-11-23
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Uretero1 Ureteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211347. 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 Uretero1 Ureteroscope System?

Uretero1 Ureteroscope System is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is STERIS Corporation. The 510(k) number is K211347.

When did Uretero1 Ureteroscope System receive FDA 510(k) clearance?

Uretero1 Ureteroscope System received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211347.

Who is the listed applicant for Uretero1 Ureteroscope System?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uretero1 Ureteroscope System?

The FDA product code for Uretero1 Ureteroscope System is FGB.

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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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