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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscopic cholecystectomy kit
Regulation Description Manual surgical instrument for general use.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodePKE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Falling 2 2
Break 2 2
Detachment Of Device Component 1 1
Delivered as Unsterile Product 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Packaging Compromised 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
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