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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enema kit
Regulation Description Enema 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 CodeFCE
Regulation Number 876.5210
Device Class 1

Premarket Reviews

Device Problems
Improper or incorrect procedure or method 3
No Known Device Problem 1
Unintended ejection 1
Instruction for use issue 1
Device, or device fragments remain in patient 1
Use of Device Issue 1
Total Device Problems 8