BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ETHICON ENDO-SURGERY, LLC

    Reg #: 3005075853 · FEI: 3005075853 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    75
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    ETHICON ENDO-SURGERY, LLC
    Registration Number
    3005075853
    FEI Number
    3005075853
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    475 CALLE C
    City
    GUAYNABO
    State
    PR
    ZIP
    00969
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121550

    Owner / Operator

    Firm Name
    ETHICON ENDO-SURGERY, LLC
    Operator Number
    9071406
    Address
    4545 Creek Rd
    City
    Cincinnati
    State
    OH
    Postal Code
    45242
    Country
    US
    Correspondent
    Emily Nesbitt

    Products

    Device Name Product Code
    Staple, Implantable GDW
    Instrument, Ultrasonic Surgical LFL
    Laparoscope, General & Plastic Surgery GCJ
    Stapler, Surgical GAG
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Applier, Hemostatic Clip HBT
    Electrocautery, Gynecologic (And Accessories) HGI
    Applier, Surgical, Clip GDO
    Clip, Implantable FZP
    Instrument, Manual, Surgical, General Use MDM
    Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
    Apparatus, Pneumoperitoneum, Automatic FDP
    Cannula, Surgical, General & Plastic Surgery GEA
    Apparatus, Exhaust, Surgical FYD
    Endoscopic Tissue Approximation Device OCW
    Insufflator, Laparoscopic HIF
    Tray, Surgical LRP
    Staple, Removable (Skin) GDT

    Proprietary Names

    Ethicon Endo-Surgery; Linear Cutter PROXIMATE HARMONIC ACE Harmonic 500 ENDOPATH ECHELON HARMONIC FOCUS LIGACLIP - Endoscopic Clip Applier CONTOUR ENSEAL® X1 Curved Jaw Tissue Sealer LAPRA-TY LIGACLIP HARMONIC EnSeal DUALTO™ Energy System ENDOPATH XCEL Harmonic HD1000i shears, 20cm, 36cm CONTOUR TRANSTAR 12-L 12MM Endoscopic ROTATING MULTIPLE CLIP APLLIER Circular Sizer ETHICON 3D Reloads; ETHICON 4000 Staplers 60 mm ECHELON ENDOPATH Staple Line Reinforcement ENDOPOUCH Enseal X1 Large Jaw Tissue Sealer ETS-FLEX45 Articulating Endoscopic Linear Cutters Echelon Contour Curved Cutter with reloads. Ethicon™ Circular Stapler, XL Sealed and Ethicon™ Circular Stapler ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter ENDOPATH PNEUMONEEDLE Ethicon Generator 11 FLEXIPATH ECHELON FLEX POWERED HARMONIC Scallop Blade and Generator G11 ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating Endopath Electrosurgery Probe Plus II ENSEAL X1 Tissue Sealers, Curved and Straight, 25cm, 37cm, 45cm Linear Cutter Ethicon Endo-Surgery HARMONIC ACE® Curved Shears HARMONIC Gray Handpiece HARMONIC Blue Handpiece Echelon Flex Powered Plus LIGACLIP MCA MEGADYNE Energy Signal Cable Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier ENSEAL ENDOPATH BIPOLAR ACTIVE/RETURN CORD ADVANT ValuTrus ENDOPATH ILS Echelon Linear Cutter ENDOPATH ULTRA VERESS INSUFFLATION NEEDLE ENSEAL® X1 Straight Jaw Tissue Sealer ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler ECHELON™ 45 Endopath® Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology) Generator G11 Harmonic 1100 ULTRACISION HARMONIC ACE+ HARMONIC FOCUS Shears + Adaptive Tissue Technology LIGAMAX ECHELON ENDOPATH™ Staple Line Reinforcement ENDOPATH DEXTRUS Enseal X1 Tissue Sealer ETHICON 4000 Staplers 60 mm ETHICON 3D Reloads Harmonic Focus Long Shears + Adaptive Tissue Technology ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear cutters ECHELON FLEX 60mm Powered Plus Articulating Endoscopic Linear cutters ETHICONTM 3D 45mm Reload ETHICONTM 4000 45mm Stapler ECHELON 60 Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface Technology) XCEL ENDOSUTURE SYSTEM Echelon Circular Powered Stapler

    Establishment Types

    Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility