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The AutoBand Multiple Band Ligator is used to band esophageal varices or hemorrhoids in the colon. The device is intended for single use only.

The AutoBand Multiple Band Ligator device consists of the applicator unit (including the band barrel, handle, activation wheel, wheel grip, beaded string, interior stainless steel trigger wire, and fixation arm), a fixation strap, and the ligation bands that are mounted on the barrel. The device is intended for single use and is supplied non-sterile. The ligation bands are intended for endoscopic placement in the esophagus or colon, with the trigger wire introduced through the biopsy port of the endoscope. Each AutoBand barrel is pre-loaded with seven bands. Models are manufactured for compatibility with either gastroscopes or colonoscopes. AutoBand model designations also are differentiated based on compatibility with different endoscope manufacturers.

The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations. The Auto-Band Ligator incorporates the following product features: - Automatic Reverse Movement to START position after each release - Snap Fixation system ensures stable fixation on the scope - Adjustable Snap Fixation System facilitates fixation on all brands of scopes - Precision One-Step Release Mechanism of bands - Only a single band can be released at a time - Latex or Latex Free Rubber Bands - Available in 5, 6, 7, 8 or 10 band configurations

The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands. The Auto-Band Ligator incorporates the following product features: Automatic Reverse Movement to START position after each release. Snap Fixation system ensures stable fixation on the scope. Adjustable Snap Fixation System facilitates fixation on all brands of scopes. Precision One-Step Release Mechanism of bands. Only a single band can be released at a time. Latex Free Rubber Bands. Available in 5, 7 or 10 band configurations.

The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking, . - Hemostasis for: ● - o Mucosal and submucosal defects < 3 cm - Bleeding ulcers o - o Arteries < 2 mm - o Polyps < 1.5 cm in diameter - o Diverticula in the colon - Anchoring to affix jejunal feeding tubes to the wall of the small bowel, . - Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.

The InScope™ Mult-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips.

The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.

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The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.

The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted rubber latex ligating bands. The ligating unit is attached to the handle by the activating sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm diameter. Four endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 11.5 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. The X-large adapter fits 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope. The modified design differs from the predicate device in that the ligating tip has been modified to improve the sealing integrity of the lip seal during aspiration and to improve the smooth actuation of the Band Driver over the Band Carrier by the addition of 12 ribs to the Band Driver. The sheath attaches to the handle assembly, which can be held in the physician's hand or attached to the endoscope sheath outside of the patient. The bands are deployed by depressing the thumb paddle on the handle assembly causing the bands to be pushed/deployed off of the band carrier. The modified device mounts flush with the tip of the endoscope, as does the predicate device, to allow maximum visualization. The modified and current device tips extend beyond the distal tip of the endoscope allowing variceal tissue to be suctioned into the band carrier cylinder for ligation.

The Bard® UltraView™ Multiple Band ligator is used for endoscopic ligation of esophageal varices.

The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted natural rubber latex ligating bands. The ligating unit is attached to the handle by the activating cable sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm inner diameter. Three endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 10.8 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. No adapter is required for 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope.

The HX-5/6-1 Clip Fixing Devices are intended to be used with an Olympus endoscope for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal/sub-mucosal defects <3cm, (b) bleeding ulcers, (c) arteries <2mm, (d) polyps <1.5cm in diameter, (e) diverticula in the colon, (3) as a method for endoscopic closure of (a) mucosal/sub-mucosal defects <3cm, (b) polyps <1.5cm in diameter, (c) diverticula in the colon, (d) fistulas <20mm that can be treated conservatively.

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The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.

The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components. 1. The Ligating Unit: The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder. 2. Handle Unit with Trip Wire and Scope Fastener: The main component of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.