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

    ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

    K Number: K131705 · Decision Jul 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    13
    Review Days
    20

    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
    ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
    K Number
    K131705
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, Formerly US Surgical A Divison of Tyco H
    Date Received
    June 11, 2013
    Decision Date
    July 1, 2013
    Product Code
    GDW
    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
    GDW Staple, Implantable

    Similar 510(k) Clearances

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

    ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

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

    K Number Device Name
    K130532 IDRIVE ULTRA STERILIZATION TRAY
    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
    K112349 VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
    Search all 13 clearances from Covidien, Formerly US Surgical A Divison of Tyco H →