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

    POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT

    K Number: K122494 · Decision Mar 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    10
    Review Days
    223

    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
    POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
    K Number
    K122494
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemostasis, LLC
    Date Received
    August 16, 2012
    Decision Date
    March 27, 2013
    Product Code
    LYA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYA Splint, Intranasal Septal

    Similar 510(k) Clearances

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

    TurbAlign

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Epi-Stop Nasal Gel/epistaxis pack

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SPIWay Endonasal Access Guide

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Novapak Nasal Sinus Packing and Stent

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ChitoZolve

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SPIWay Endonasal Access Guide

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Hemostasis, LLC

    K Number Device Name
    K234131 Resolv Endoscopic Hemostat System
    K220326 PosiSep X BAM Hemostat Dressing/Intranasal Splint
    K210411 PosiSep EAR Fragmentable Ear Dressing
    K142348 OsteoSeal Bone Hemostat
    K122886 NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
    K120958 POSISEP AND POSISEP X HEMOSTAT DRESSINGS
    K102459 NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
    K072900 EXCELARREST FOAM
    K070211 TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM