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• Instrument for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions. Marking of lesions.
• The OTSCneo clip is indicated for clip placement within the GI tract for the purpose of:
  • Endoscopic marking
• Hemostasis for:
  • Mucosal/submucosal defects < 3 cm
  • Bleeding ulcers
  • Arteries < 2 mm
  • Polyps < 1.5 cm in diameter
  • Diverticuli in the colon
• Closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

NOTE: The OTSCneo System Set is not indicated for stent fixation. For stent fixation, use the stentfix OTSC® System Set.

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments or suction are used via endoscope working channels for mobilization and retraction of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a manual thread mechanism.

Contents of the OTSCneo System Set are:

• Application cap (with spout, application ring, thread, clip mounted on the cap)
• Hand Wheel
• Thread Retriever

In line with cleared indications, clip application with the subject device can be used for hemostasis, treatment of lesions, or marking of lesions in the GI tract.

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