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510(k) Data Aggregation

    K Number
    K252929

    Validate with FDA (Live)

    Device Name
    Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
    Manufacturer
    Anhui Happiness Workshop Instruments Co., Ltd.
    Date Cleared
    2026-04-09

    (206 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253268

    Validate with FDA (Live)

    Device Name
    Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
    Manufacturer
    CMT Health PTE., Ltd.
    Date Cleared
    2026-04-08

    (191 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252270

    Validate with FDA (Live)

    Device Name
    Hemoclip
    Manufacturer
    Hangzhou AGS MedTech Co., Ltd.
    Date Cleared
    2026-04-08

    (261 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253905

    Validate with FDA (Live)

    Device Name
    PrimeSight UltraView System
    Manufacturer
    Cogentix Medical, Inc.
    Date Cleared
    2026-04-07

    (123 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260521

    Validate with FDA (Live)

    Device Name
    ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
    Manufacturer
    Zhuhai Pusen Medical Technology Co., Ltd.
    Date Cleared
    2026-04-06

    (48 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252809

    Validate with FDA (Live)

    Device Name
    in2 Smart (in2S)
    Manufacturer
    Virility Medical , Ltd.
    Date Cleared
    2026-04-06

    (215 days)

    Product Code
    QRC
    Regulation Number
    876.5026
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253056

    Validate with FDA (Live)

    Device Name
    Disposable Stone Extraction Basket
    Manufacturer
    Zhejiang Soudon Medical Technology Co., Ltd.
    Date Cleared
    2026-04-03

    (193 days)

    Product Code
    LQR
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260724

    Validate with FDA (Live)

    Device Name
    MAGENTIQ-COLO (ME-APDS)
    Manufacturer
    Magentiq Eye, Ltd.
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    QNP
    Regulation Number
    876.1520
    Type
    Special
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254153

    Validate with FDA (Live)

    Device Name
    Single-use Video Scope; PB Digital Controller
    Manufacturer
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2026-04-03

    (102 days)

    Product Code
    FBN
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252943

    Validate with FDA (Live)

    Device Name
    GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
    Manufacturer
    Convatec Limited
    Date Cleared
    2026-04-01

    (198 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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