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510(k) Data Aggregation

    K Number
    K253598

    Validate with FDA (Live)

    Device Name
    InjecSURE Injection System
    Manufacturer
    Carbon Medical Technologies, Inc.
    Date Cleared
    2026-03-31

    (133 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K890328,K982890,K193007,K180214
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K890328, K982890, K193007

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InjecSURE® Injection System is intended for use as an accessory to currently marketed cystoscopes to allow delivery of injectable materials into urethral tissues of the lower urinary tract during cystoscopic procedures.

    Device Description

    The InjecSURE Injection System includes sterile, single-use components designed for one patient, featuring a 20 Ga, 5-inch (127 mm) needle—available with either a pencil-point or spinal tip—and a disposable sheath. The disposable sheath is compatible with 2.7 mm cystoscopes of various lengths.

    The sheath attaches to a cystoscope to provide a guided pathway for the needle to reach the desired location.

    AI/ML Overview

    N/A

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