BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PHARMASEAL WOUND IRRIGATION DEVICE

    K Number: K874022 · Decision Dec 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    64
    Review Days
    89

    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
    PHARMASEAL WOUND IRRIGATION DEVICE
    K Number
    K874022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    October 2, 1987
    Decision Date
    December 30, 1987
    Product Code
    FQH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FQH Lavage, Jet

    Similar 510(k) Clearances

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

    BD Surgiphor™ Antimicrobial Irrigation System (910110)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ERBEJET® 2 System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Armis VeriCyn Wound Wash

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERSAJET Hydrosurgery System (III)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Surgiphor™ Antimicrobial Irrigation System

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by American Pharmaseal Div. Ahsc

    K Number Device Name
    K874517 PHARMASEAL RUBBER URETHRAL CATHETER
    K874045 PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
    K873359 AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
    K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
    K872917 JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
    K871429 ANTIMICROBIAL FOLEY CATHETER
    K871770 AMERICAN PHARMASEAL WOUND DRESSING
    K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
    K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
    K870941 PHARMASEAL WOUND CARE DRESSING PAD
    Search all 64 clearances from American Pharmaseal Div. Ahsc →