510(k) K162319
K162319 is an FDA 510(k) premarket notification submitted by Fairhaven Health, LLC for the device "BabyDance Fertility Lubricant". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible), a Class II device regulated under 21 CFR 884.5300. Fairhaven Health, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2017
- Date Received
- August 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
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.