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FDA 510(k)

URETERO-RENOSCOPE

K-Number: K992527 · 1999-10-13

ApplicantFiber Imaging Technologies, Inc.
Decision Date1999-10-13
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERO-RENOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Fiber Imaging Technologies, Inc.. It received FDA 510(k) clearance on 1999-10-13 under 510(k) number K992527. 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 URETERO-RENOSCOPE?

URETERO-RENOSCOPE is a medical device that received FDA 510(k) clearance on 1999-10-13. The listed applicant is Fiber Imaging Technologies, Inc.. The 510(k) number is K992527.

When did URETERO-RENOSCOPE receive FDA 510(k) clearance?

URETERO-RENOSCOPE received FDA 510(k) clearance on 1999-10-13, under 510(k) number K992527.

Who is the listed applicant for URETERO-RENOSCOPE?

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

What is the FDA product code for URETERO-RENOSCOPE?

The FDA product code for URETERO-RENOSCOPE 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 Fiber Imaging Technologies, 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.

K993300COLDLIGHTSOURCE PL3000K992437SCHOELLY RIGID ENDOSCOPESK992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESK991560NASO-LARYNGO-PHARYNGOSCOPE

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

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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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