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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trocar, reprocessed
Definition Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNMK
Regulation Number 870.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Low Blood Pressure/ Hypotension 2 2
Pericardial Effusion 2 2

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