BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PROSYS SAMEC LA

    K Number: K963265 · Decision Oct 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    81
    Review Days
    66

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PROSYS SAMEC LA
    K Number
    K963265
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    August 20, 1996
    Decision Date
    October 25, 1996
    Product Code
    EXJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EXJ Device, Incontinence, Urosheath Type, Sterile

    Similar 510(k) Clearances

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

    BOUSER'S URINAL

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    COMFORT CATH CHOICE MALE EXTERNAL CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    SELF RETAINING MALE EXTERNAL URINARY CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology
    View all

    Other Clearances by Convatec, A Division of E.R. Squibb & Sons

    K Number Device Name
    K013814 ABSORBENT ANTIMICROBIAL WOUND DRESSING
    K990964 SIGNADRESS DUODERM DRESSING
    K984388 HA ABSORBENT WOUND DRESSING
    K980720 NONWOVEN PAD
    K980382 NON-WOVEN COMPRESS
    K974823 NONWOVEN DRESSING
    K974205 KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
    K974304 GERMICIDAL CLOTH
    K973632 DUODERM CGF CONTROL GEL FORMULA DRESSING
    K972530 CONVATEC ODOR CONTROL WOUND DRESSING
    Search all 81 clearances from Convatec, A Division of E.R. Squibb & Sons →