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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic central control unit
Definition To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Product CodeODA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH+NEPHEW
  SUBSTANTIALLY EQUIVALENT 1

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