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

    MONOJECT INSULIN SYRINGE

    K Number: K033373 · Decision Nov 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    14
    Review Days
    22

    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
    MONOJECT INSULIN SYRINGE
    K Number
    K033373
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare
    Date Received
    October 22, 2003
    Decision Date
    November 13, 2003
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

    Similar 510(k) Clearances

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

    Profoject™ Safety Pen Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Verisafe Safety Sterile Needles (SSN)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRESSONE™

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pen Needle

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

    Other Clearances by Tyco Healthcare

    K Number Device Name
    K071049 DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
    K070685 KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
    K070653 KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
    K061492 MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
    K042709 DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
    K040897 DOVER ROB-NEL CATHETER
    K040649 KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
    K041243 DOVER RED RUBBER ROBINSON CATHETER
    K032438 MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
    K033453 KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
    Search all 14 clearances from Tyco Healthcare →