FDA Product Code NUC: Lubricant, Personal
This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
Leading manufacturers include Global Protection Corp., Rb Health (Us), LLC and CC Wellness, LLC.
FDA 510(k) Cleared Lubricant, Personal Devices (Product Code NUC)
About Product Code NUC - Regulatory Context
510(k) Submission Activity
240 total 510(k) submissions under product code NUC since 2000, with 240 receiving FDA clearance (average review time: 187 days).
Submission volume has declined in recent years - 19 submissions in the last 24 months compared to 24 in the prior period.
FDA Review Time
FDA review times for NUC submissions have been consistent, averaging 166 days recently vs 189 days historically.
NUC devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →