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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gynecologic power morcellator and containment system
Definition A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery.
Product CodeSIM
Regulation Number 884.4075
Device Class 2


Premarket Reviews
ManufacturerDecision
CLARIA MEDICAL, INC.
  GRANTED 1

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