PEB — Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Class II
FDA product code PEB covers "Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible", a Class II medical device regulated under 21 CFR 884.5300. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PEB
- Device Class
- Class II
- Regulation Number
- 884.5300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212885 | cc wellness | Actively Trying Personal Lubricant Rose Scented | February 11, 2022 |
| K212705 | cc wellness | Actively Trying Personal Lubricant Unfragrance | February 9, 2022 |
| K193450 | church and dwight co | Pre-Seed Fertility Lubricant | July 23, 2020 |
| K190872 | good clean love | BioGenesis Fertility Lubricant | November 7, 2019 |
| K182585 | united consortium | JO Actively Trying Personal Lubricant | April 26, 2019 |
| K162319 | fairhaven health | BabyDance Fertility Lubricant | April 28, 2017 |
| K141132 | biofilm | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | January 9, 2015 |
| K131355 | sasmar | CONCEIVE PLUS | November 7, 2013 |
| K072741 | ingfertility | PRE-VA VAGINAL LUBRICANT | July 16, 2008 |
| K051436 | ingfertlity | PRE' VAGINAL LUBRICANT | October 13, 2006 |