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The HSW Arthroscope and accessories is a tubular endoscopic device with accessory devices which attach to the Arthroscope and is intended to examine and / or perform surgery on the interior of a joint. Arthroscopic minimal invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release).

The Henke Sass Wolf of America's Arthroscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf of America's current Arthroscope and the Smith & Nephew Arthroscope. The only difference from the current Henke Sass Wolf of America's Arthroscope is the new intended use for hip surgery. This indication for use is already in place for the Smith & Nephew Arthroscope. The arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. A series of rod lenses relay the image along the length of the tube. At the proximal end, in the case of a direct view model, an ocular lens forms an image for viewing directly with the human eye. In the case of a videoarthroscope, a proximal coupling lens relays the image to a CCD (charged couple device used as an electronic video sensor chip). Arthroscopes generally come in two diameters, 2.7mm and 4.0mm, although other sizes are sometimes offered. Larger size arthroscopes are used for general viewing. This is due to the preferable larger and brighter image achievable with larger diameter optical components. The small sizes are used where access to the surgical site is restricted. Arthroscopes generally come in several "directions of view", 0°, 30°, 70°, 90° and 110°, though others are sometimes offered. The center axis of the field of view of the 0° scope is along the normal axis of the Arthroscope. The other "direction of view" instruments are referenced from the scope normal axis. The various "directions of view" permit or facilitate viewing of different parts of the relevant anatomy. All arthroscopes also contain glass fibers for illumination of the surgical site. Henke Sass Wolf Arthroscopes are provided in Autoclavable and Non-Autoclavable models.

The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver. Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.

The Henke Sass Wolf of America's Bariatric Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf GmbH HSW Laparoscopy Set - K941967 and the Stryker - K993045. This Bariatric version is longer (up to 550mm) so that it is capable of performing the same types of procedures on morbidly obese segments of the patient population. Diameter: 5mm - 10mm Length: 280mm to 550mm Direction of View: 0, 30, 45 Degrees Field of View: 75 Degrees Shaft: 300 Series Stainless Steel Body: Stainless Steel Sidearm: Stainless Steel Eyepiece: P.E.E.K. Lenses: Glass or Sapphire Adapters for connection to all conventional light-guides are supplied as standard. The device is intended to be sterilized prior to use. The Bariatric Laparoscopes are designed to facilitate cleaning and disinfection as were the predicate devices. There is no difference in design and material that would impact the sterilization validation conducted for the HSW predicate device. Instructions for cleaning and sterilization are included in the instructions for use. Sterilization and disinfection validation for predicate devices included EtO, Steris, and Sterrad is performed to assure an SAL of 10-6 per AAMI / ISO Standards.

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device.

Intended for use in Endoscopic Saphenous Vein harvesting procedures.

The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical. For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm. The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.

The Henke Sass Wolf Hysterscopic Resectoscopes and Accessories are intended to enable the viewing and resection/coagulation of soft tissue encountered in but not limited to gynecologic, urologic diagnostic and surgical procedures. The HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes. The Resectoscopes and Accessories are indicated for use in diagnostic examination and therapeutic surgical procedures of but not limited Urological and Gynecological Fields. The surgical applications to: may include: Tissue Cutting, removal, and dissection as required or encountered in but not limited to: - Excision of intrauterine myomas - Excision of intrauterine polyps - Lysis of intrauterine adhesions - . Incision of uterine septa

The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories are reusable handheld instruments designed for a means of performing diagnostic and therapeutic procedures. The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories (available in various lengths and Sizes) have the same operating principals and intended uses as many of the competitive hysteroscopic resectoscopes and accessories already in commercial distribution

The Henke-Sass Wolf, Disposable Hypodermic Single Lumen Needle is Intended to be used for the purpose of injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin.

The HENKE -SASS , WOLF FINE-JECT® Disposable Needles are sterile hypodermic Single Lumen Needles, packaged individually for single patient use. The HENKE SASS WOLF Needles have the same operating principals and intended uses as the predicate devices already in commercial distribution

The HENKE- SASS, WOLF Sinuscope is intended to provide the physician with a means of endoscopic diagnostic and therapeutic sinus surgical procedures. The HENKE-SASS WOLF of America Inc. Sinuscope Accessories include Sheaths - to establish surgical access and the removal of debris and body fluids from the surgical site and to provide irrigation of the site with a sterile solution such as saline water. The Sinuscope and accessories are indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.

The HENKE-SASS, WOLF Sinuscopes are reusable hand-held instruments designed for a means of performing diagnostic and therapeutic sinus procedures. The HENKE-SASS, WOLF Sinuscopes and accessories have the same operating principals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution