BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PICO Single Use Negative Pressure Wound Therapy System

    K Number: K163387 · Decision Apr 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    18
    Review Days
    137

    Basic Information

    Device Name
    PICO Single Use Negative Pressure Wound Therapy System
    K Number
    K163387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Medical Limited
    Date Received
    December 2, 2016
    Decision Date
    April 18, 2017
    Product Code
    OMP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OMP Negative Pressure Wound Therapy Powered Suction Pump

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OMP), ordered by most recent decision date.

    Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Genadyne DUO NPWT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VERSA Negative Pressure Wound Therapy System (VCMPP-100)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Negative Pressure Wound Therapy Device (V-Move, V-Grand)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NEXA™ NPWT System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Smith & Nephew Medical Limited

    K Number Device Name
    K242146 BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
    K223526 ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
    K220964 VERSAJET Hydrosurgery System (III)
    K223041 Renasys Edge (66803126)
    K202783 Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
    K202157 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
    K191760 PICO 14 Single Use Negative Pressure Wound Therapy System
    K181822 RENASYS Touch; RENASYS Y-Connector
    K182323 PICO 7Y Single Use Negative Pressure Wound Therapy System
    K181204 RENASYS Y-Connector; RENASYS TOUCH
    Search all 18 clearances from Smith & Nephew Medical Limited →