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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appendiceal scope and accessories, flexible
Regulation Description Endoscope and accessories.
Definition Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall.
Product CodeSHU
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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