Profile: Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvic health and wound closure. Our PVP™ is the first and only umbilical hernia repair device featuring lighter-weight mesh and exclusive absorbable deployment technology. It contours with the body for secure placement. It is partially absorbable and macroporous for a natural healing process. It is strong yet flexible. Our Dermabond® adhesive is a sterile, liquid topical skin adhesive designed to repair lacerations and to close surgical incisions. It provides a strong, flexible, needle-free wound closure.

The company has ~9000 employees. NYSE:JNJ (SEC Filings)

FDA Registration Number: 3003702646
US Agent: Haroldo Delgado / Ethicon Inc.
Phone: +1-(954)-441-3090  Fax: +1-(954)-249-8781  E-Mail:

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• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General Bandages

• General Diagnostic Supplies

• General Medical Supplies

• General Orthopedic Supplies

• General Purpose Cabinet Casework

• General Surgery Supplies

• General Surgical Aids

• General Surgical Instruments

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General Sutures/Needles

• General Urology Supplies

• Graspers

• Gynecologic Electrocautery and Accessories (FDA Code: HGI / 884.4120) A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Hardy Bayonet Forceps

• Helical Stone Extractors

• Hemorrhoidal Ligator (FDA Code: FHN / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Hemostatic Clip, Implant (FDA Code: MCH / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Hemostatic Dressings

• Hemostats

• Hernia Repair Grafts

• Horizontal Curved Microscissors

• Horizontal Scissors

• Hospital pull Carts

• Hospital Push Carts

• Hydrophilic Wound Dressings (FDA Code: NAC / 878.4018) A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Hysteroscope and Accessories (FDA Code: HIH / 884.1690) A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Hysteroscopy System

• Implantable Clip (FDA Code: FZP / 878.4300)

• Implantable Radiographic Marker (FDA Code: NEU / 878.4300)

• Implantable Staple (FDA Code: GDW / 878.4750) An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Inferior Oblique Muscle Forceps

• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

• Interference Screws

• Intraocular Foreign-Body Forceps

• Iris Suturing Forceps

• Iris Tissue Forceps

• Island Dressings

• Jeweler Type Forceps

• Kidney Stone Extractors

• Kleppinger Forceps

• Kremer Angled Fixation Forceps

• Kremer Corneal Fixation Forceps

• Lacrimal System, Bayonette Forceps

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730) A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.