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.
Leading manufacturers include CC Wellness, LLC, United Consortium and Good Clean Love, Inc..
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
Cleared
Feb 11, 2022
Actively Trying Personal Lubricant Rose Scented
CC Wellness, LLC
Obstetrics & Gynecology
154d
Cleared
Feb 09, 2022
Actively Trying Personal Lubricant Unfragrance
CC Wellness, LLC
Obstetrics & Gynecology
167d
Cleared
Jul 23, 2020
Pre-Seed™ Fertility Lubricant
Church & Dwight Co., Inc.
Obstetrics & Gynecology
223d
Cleared
Nov 07, 2019
BioGenesis Fertility Lubricant
Good Clean Love, Inc.
Obstetrics & Gynecology
218d
Cleared
Apr 26, 2019
JO Actively Trying Personal Lubricant
United Consortium
Obstetrics & Gynecology
218d
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.