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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trocar
Product CodeDRC
Regulation Number 870.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 5
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 63 63
2015 51 51
2016 62 62
2017 70 70
2018 85 85
2019 95 95
2020 108 108
2021 43 43

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Nov-13-2021
2 Cook Inc. I Mar-13-2019
3 Cook Incorporated II Apr-12-2024
4 CooperSurgical, Inc. II May-01-2018
5 CooperSurgical, Inc. D.B.A. Lone Star Medical Products II Oct-29-2014
6 Ethicon Endo-Surgery Inc II Jun-26-2015
7 Instrumed International, Inc. II Dec-16-2014
8 Medical Device Technologies, Inc. II Jul-13-2010
9 Merit Medical Systems, Inc. II Mar-16-2021
10 Merit Medical Systems, Inc. II Apr-12-2016
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