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Endoscopic Introducer.pdf

K123013.pdf
Preview of Endoscopic Introducer
🔗 Source: accessdata.fda.gov
📊 Size: 146 KB
📄 Pages: 5 pages
⬇️ Downloads: 91

Summary

Novadaq Technologies Inc.'s 510(k) summary for the Disposable Rigid Scope Introducer, an endoscopic access overtube, indicates it is substantially equivalent to predicate devices, including the Colonic Splinting Overtube and Shape Locking Endoscopic Overtube, with similar shape, materials, and patient effects. The device is intended for visual examination of the rectum and distal portions of the colon, with a maximum insertion length of 25cm, and features an insufflation port. The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls provisions of the Act.

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Description

Novadaq Technologies Inc.'s 510(k) summary for the Disposable Rigid Scope Introducer, an endoscopic access overtube, indicates it is substantially equivalent...

Technical Information

  • File Format: PDF
  • File Size: 146 KB
  • Pages: 5
  • Language: EN
  • Total Downloads: 91
  • Last Updated: 1 week ago

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This PDF document about Endoscopic Introducer provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into Endoscopic Introducer.

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