BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ETHICON ENDO-SURGERY, INC.

    Reg #: 1527736 · FEI: 1527736 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    67
    Establishment Types
    1
    Classifications
    20

    Registration Details

    Registration Name
    ETHICON ENDO-SURGERY, INC.
    Registration Number
    1527736
    FEI Number
    1527736
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4545 CREEK RD.
    City
    Cincinnati
    State
    OH
    ZIP
    45242
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012176

    Owner / Operator

    Firm Name
    ETHICON ENDO-SURGERY, INC.
    Operator Number
    9010225
    Address
    4545 CREEK RD., ML #39
    City
    Cincinnati
    State
    OH
    Postal Code
    45242
    Country
    US
    Correspondent
    Emily Nesbitt

    Products

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

    Proprietary Names

    HARMONIC Harmonic HD 1000i Shears, 20cm, 36cm Echelon Circular Powered Stapler XCEL ENDOPATH HARMONIC Gray Handpiece HARMONIC Blue Handpiece LIGAMAX ETHICONTM 3D 45mm Reload ETHICONTM 4000 45mm Stapler ENDOPATH XCEL Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier Endopath Electrosurgery Probe Plus II ValuTrus ADVANT PROXIMATE ENSEAL LIGACLIP Harmonic Scalpel Sterile Tray Echelon Flex Powered Plus ECHELON ENDOPATH™ Staple Line Reinforcement Mesh, surgical, absorbable, staple line reinforcement ECHELON 3D Reload ECHELON 4000 Stapler 60 mm MEGADYNE Energy Signal Cable CONTOUR Gen11 Accessories Ligaclip Endoscopic Clip Applier ETHICON 3D Reloads; ETHICON 4000 Staplers 60 mm ECHELON Ethicon™ Circular Stapler, XL Sealed and Ethicon™ Circular Stapler DUALTO™ Energy System LIGACLIP MCA Harmonic Focus Long Shears + Adaptive Tissue Technology ECHELON 60 Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface Technology) HARMONIC ACE Harmonic 500 Enseal X1 Large Jaw Tissue Sealer ENSEAL 1X Tissue Sealer, Curved Jaw, Articulating Ethicon Endo-Surgery Linear Cutter ENDOSUTURE SYSTEM Echelon Contour Curved Cutter with reloads ENSEAL® X1 Curved Jaw Tissue Sealer ECHELON™ 45 Endopath® Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology) ETHICON Linx Esophagus Sizing Tool ENSEAL X1 Tissue Sealers, Curved and Straight, 25cm, 37cm, 45cm ENSEAL® X1 Straight Jaw Tissue Sealer Echelon Linear Cutters Endopath BIPOLAR FLEXIPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters ECHELON FLEX POWERED Harmonic 1100 Generator G11 HARMONIC ACE+ 12-L 12MM Endoscopic ROTATING MULTIPLE CLIP APLLIER ENSEAL X1 Tissue Sealer ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear cutters ECHELON FLEX 60mm Powered Plus Articulating Endoscopic Linear cutters ENDOPOUCH LAPRA-TY HARMONIC ACE® Curved Shears BASX HARMONIC FOCUS Shears + Adaptive Tissue Technology Harmonic

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility