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Summary.pdf

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🔗 Source: accessdata.fda.gov
📊 Size: 170 KB
👤 Author: Choi, Minjin
⬇️ Downloads: 229

Summary

The FDA has determined that the Sof-Flex Ureteral Stent Set is substantially equivalent to legally marketed predicate devices, and therefore, Cook Incorporated may market the device, subject to general controls provisions of the Act, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. The device is classified as Class II and is intended for temporary internal drainage from the ureteropelvic junction to the bladder, with indications for use in relieving obstruction in benign, malignant, and post-traumatic conditions.

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The FDA has determined that the Sof-Flex Ureteral Stent Set is substantially equivalent to legally marketed predicate devices, and therefore, Cook Incorporated...

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  • File Format: PDF
  • File Size: 170 KB
  • Pages: 7
  • Language: EN
  • Author: Choi, Minjin
  • Total Downloads: 229
  • Last Updated: 7 days ago

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