PEB · Class II · 21 CFR 884.5300

FDA Product Code PEB: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Sexual Activity And Supplement The Body's Natural Lubrication. This Device May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. This Device Is Compatible With Sperm, Oocytes, And Embryos And Can Be Used By Couples Trying To Conceive. This Device May Also Be Used During Fertility Interventions To Facilitate Entry Of Diagnostic And Therapeutic Devices.

10
Total
10
Cleared
246d
Avg days
2006
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Devices (Product Code PEB)

10 devices
1–10 of 10
No devices found for this product code.

About Product Code PEB - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code PEB since 2006, with 10 receiving FDA clearance (average review time: 246 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.