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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trocar kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOKX
Regulation Number 884.1720
Device Class 2

MDR Year MDR Reports MDR Events
2017 2 2
2019 3 3
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Material Disintegration 2 2
Material Fragmentation 2 2
Microbial Contamination of Device 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
No Clinical Signs, Symptoms or Conditions 1 1

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