BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ETHICON, INC.

    Reg #: 3017102971 · FEI: 3017102971 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    100
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    ETHICON, INC.
    Registration Number
    3017102971
    FEI Number
    3017102971
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1000 Route 202
    City
    Raritan
    State
    NJ
    ZIP
    08869
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182873
    PMA Number
    P880047

    Owner / Operator

    Firm Name
    ETHICON INC.
    Operator Number
    2210968
    Address
    1000 US Highway 202 S.
    City
    Raritan
    State
    NJ
    Postal Code
    08869
    Country
    US
    Correspondent
    Reynaldo Librojo

    Products

    Device Name Product Code
    Barrier, Absorbable, Adhesion MCN
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Cannula, Surgical, General & Plastic Surgery GEA
    Suture, Nonabsorbable GAO
    Mesh, Surgical, Polymeric FTL
    Fibrin Sealant Preparation Device MZM
    Staple, Implantable GDW
    Needle, Cerclage, Gynecological HDH
    Wax, Bone MTJ
    Accessories, Catheter KGZ
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Silk GAP
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Instrument, Surgical, Disposable KDC
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Cutaneous Tissue Adhesive With Mesh OMD
    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives SGV
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Suture, Absorbable, Synthetic GAN
    Clip, Implantable FZP
    Device, Occlusion, Umbilical FOD
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Catheter, Irrigation GBX
    Suture, Absorbable, Natural GAL
    Laparoscope, General & Plastic Surgery GCJ
    Electrode, Pacemaker, Temporary LDF
    Catheter And Tip, Suction JOL
    Agent, Absorbable Hemostatic, Non-Collagen Based LMG

    Proprietary Names

    INTERCEED GYNECARE INTERCEED Absorbable Adhesion Barrier STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Endoknot/Endoloop made with Coated Vicryl Endoknot/Endoloop made with PDS II Endoknot made with Ethibond Excel PDS™ II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture ETHI-PACK Surgical Stainless Steel Suture Nonsterile PROLENE (Polypropylene) 3D Patch PDS Plus (Polydioxanone) Antibacterial Suture VISTASEAL™ Laparoscopic Dual Applicator (45 cm Flexible) VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid) PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture SECURESTRAP Open Absorbable Strap Fixation Device MERSILENE WHITE WOVEN Polyester Fiber Ligature MERSILENE Tape MERSILENE WHITE WOVEN Polyester Fiber Strip STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device ULTRAPRO Comfort Plug PROLENE Soft Polypropylene Mesh MONOCRYL™ Plus Antibacterial Suture BONE WAX VICRYL Mesh ULTRAPRO HERNIA SYSTEM Urinary Placement Catheter (UPC) PDS Plus Antibacterial Suture VICRYL RAPIDE VICRYL™ (Polyglactin 910) Mesh ETHI-PACK* PRE-CUT SUTURE PDS PLATES PDS Flexible Plates COATED VICRYL SUTURE ETHIBOND EXCEL VALVE LOOP SUTURE PROLENE Polypropylene Mesh PROLENE Hernia System Mersilene Tape Nylon Tape PRONOVA Poly (Hexafluoropropylene - VDF) Suture VISTASEAL Dual Applicator DERMABOND PRINEO Skin Closure System (42mm) PROCEED SURGICAL MESH DERMABOND Prineo Skin Closure System (60mm) and DERMABOND Prineo Skin Closure System (22cm) ETHIZIA Hemostatic Patch PROLENE on TEFLON Pledget Suture Buttress Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture ETHICON SECURESTRAP Absorbable Strap Fixation Device MONOCRYL PLUS Antibacterial (Poliglecaprone 25) Suture PROLENE (Polypropylene) Hernia System STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device DERMABOND ProPen DERMABOND Mini Topical Skin Adhesive DERMABOND ADVANCED Topical Skin Adhesive DERMABOND™ PRINEO™ Skin Closure System (22cm) MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices LAPRA-TY SUTURE CLIP Cotton Umbilical Tape GYNEMESH Prolene Soft Mesh ULTRAPRO ADVANCED Mesh ULTRAPRO Mesh MONOCRYL (Dyed) Suture Ethicon PHYSIOMESH Open Flexible Composite Mesh BLAKE Silicone Drain J-VAC Drain Adapter BLAKE Cardio Connector STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device Modified Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture Artisyn Y-Shaped Mesh Surgical Stainless Steel Suture PERMA-HAND/Mersilk Suture/Silk Suture ETHILON Nylon Suture NUROLON ETHIBOND ETHIBOND EXCEL SURGICAL GUT SUTURE (Plain and Chromic) MERSILENE, MERSUTURE Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture ETHICON ENDOSUTURE System PDS II Suture STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices Temporary Cardiac Pacing Wire MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture ENDOSCOPIC APPLICATOR PROLENE Polypropylene Nonabsorbable Suture STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device TFE Polymer Pledgets VICRYL Woven Mesh (Polyglactin 910) VICRYL Knitted Mesh(Polyglactin 910) J-VAC Suction Reservoir J-VAC Bulb Suction Reservoir SURGICEL Fibrillar Absorbable Hemostat SURGICEL Nu-Knit Absorbable Hemostat SURGICEL Absorbable Hemostat SURGICEL Powder Absorbable Hemostatic Powder SURGICEL Endoscopic Applicator SURGICEL Snow Absorbable Hemostat

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility