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

    V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...

    K Number: K111442 · Decision Jun 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    13
    Review Days
    10

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    Basic Information

    Device Name
    V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
    K Number
    K111442
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, Formerly US Surgical A Divison of Tyco H
    Date Received
    May 24, 2011
    Decision Date
    June 3, 2011
    Product Code
    GAM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Covidien, Formerly US Surgical A Divison of Tyco H

    K Number Device Name
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    K130717 ENDO GIA RELOAD
    K130435 VERSAPORT V2 BLADELESS OPTICAL TROCAR
    K122781 RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
    K123318 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
    K121510 IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
    K120061 WOUND PROTECTOR
    K120258 DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
    K111825 ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
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