BEUDAMED
    Product Code: PZP FDA class 2 21 CFR 876.4350

    Fluid Jet Removal System

    General, Plastic Surgery

    The Fluid Jet Removal System is a surgical device that uses a high-pressure fluid jet to remove prostate tissue, used as a minimally invasive treatment for benign prostatic hyperplasia or other prostate conditions. It is classified as a Class 2 device under regulation 876.4350, requiring 510(k) premarket notification before marketing, falling within the General, Plastic Surgery (SU) medical specialty with Gastroenterology/Urology (GU) review. The product code is PZP. It is not an implant and is not life-sustaining.

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    510(k)s
    7
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    2
    Years Active
    8

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    Basic Information

    Product Code
    PZP
    Device Class
    FDA class 2
    Regulation Number
    876.4350
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    The system is used for removal of prostate tissue with a fluid jet.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K251082 HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
    K241952 AQUABEAM Robotic System (AB2000)
    K240200 HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
    K231024 AquaBeam Robotic System
    K212835 AquaBeam Robotic System
    K202961 AquaBeam Robotic System
    DEN170024 AQUABEAM System

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.