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

    MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    K Number: K011283 · Decision Oct 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    8
    Review Days
    171

    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 PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    K Number
    K011283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Kendall Company
    Date Received
    April 27, 2001
    Decision Date
    October 15, 2001
    Product Code
    NGT
    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
    NGT Saline, Vascular Access Flush

    Similar 510(k) Clearances

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

    0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Praxiject™ SP 0.9% NaCl

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Flush Syringe (Prefilled 0.9% normal saline solution)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pre-Filled Normal Saline Flush Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TK Pre-Filled Normal Saline Flush Syringe

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

    Other Clearances by The Kendall Company

    K Number Device Name
    K061936 KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
    K030209 MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
    K020089 MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
    K011941 EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
    K002902 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
    K002901 KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
    K003313 FILAC FAS TEMP ELECTRONIC THERMOMETER