BEUDAMED
    Product Code: PLL FDA class 2 21 CFR 876.1500

    Submucosal Injection Agent

    Gastroenterology, Urology

    The Submucosal Injection Agent (product code PLL) is a Class 2 gastroenterology and urology device intended for use in gastrointestinal endoscopic procedures to create a submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal mucosal lesions prior to excision, regulated under 876.1500. It requires 510(k) clearance and falls under the gastroenterology and urology medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    9
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    8
    Years Active
    9

    Basic Information

    Product Code
    PLL
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K241591 Blue Eye
    K220434 Blue Eye (TS-905)
    K221385 LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
    K200071 Blue Beacon Submucosal Injectable Solution
    K202376 EverLift Submucosal Lifting Agent
    K191923 EverLift Submucosal Lifting Agent
    K191254 EndoClot
    K180068 ORISE Gel
    K150852 SIC 8000

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.