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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscopy kit
Regulation Description Endoscope and accessories.
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 CodeFDE
Regulation Number 876.1500
Device Class 2

Device Problems
Material Integrity Problem 5
Flaked 3
Adverse Event Without Identified Device or Use Problem 2
Material Fragmentation 1
Stent 1
Break 1
Total Device Problems 13

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Customed, Inc II Sep-03-2015
3 Medline Industries Inc II Feb-11-2020

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