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FDA 510(k)

URETEROSCOPES

K-Number: K003806 · 2001-02-22

ApplicantGlobal Endoscopy, Inc.
Decision Date2001-02-22
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETEROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Global Endoscopy, Inc.. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K003806. 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 URETEROSCOPES?

URETEROSCOPES is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Global Endoscopy, Inc.. The 510(k) number is K003806.

When did URETEROSCOPES receive FDA 510(k) clearance?

URETEROSCOPES received FDA 510(k) clearance on 2001-02-22, under 510(k) number K003806.

Who is the listed applicant for URETEROSCOPES?

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

What is the FDA product code for URETEROSCOPES?

The FDA product code for URETEROSCOPES 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.

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Other records listing Global Endoscopy, Inc. 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.

K003802HYSTEROSCOPESK003805GYNECOLOGICAL LAPAROSCOPESK003831ARTHROSCOPESK003830ENT ENDOSCOPESK003803GENERAL SURGICAL LAPAROSCOPESK003807CYSTOSCOPES

View all 7 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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-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.

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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