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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vitrectomy kit
Regulation Description Vitreous aspiration and cutting instrument.
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 CodeQDY
Regulation Number 886.4150
Device Class 2

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Ejection Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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