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

    GRAFT DELIVERY SYSTEM MODEL SA-6115

    K Number: K100754 · Decision Jun 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    29
    Review Days
    84

    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
    GRAFT DELIVERY SYSTEM MODEL SA-6115
    K Number
    K100754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micromedics, Inc.
    Date Received
    March 17, 2010
    Decision Date
    June 9, 2010
    Product Code
    FMF
    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
    FMF Syringe, Piston

    Similar 510(k) Clearances

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

    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Instylla Delivery Kit

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

    Other Clearances by Micromedics, Inc.

    K Number Device Name
    K241739 Endoscopic Applicator, 41 cm
    K123847 MALLEABLE TIP ENDOSCOPIC APPLICATOR
    K122526 360 GAS ASSISTED ENDOSCOPIC APPLICATOR
    K120608 ENDOSCOPIC APPLICATOR
    K102563 SINGLE CANNULA EXTENDED APPLICATOR
    K073401 EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
    K061092 BAXTER DUPLOSPRAY MIS APPLICATOR
    K051157 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
    K050340 MICROMEDICS SPHENOID SINUS STENT
    K042834 MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
    Search all 29 clearances from Micromedics, Inc. →