Cleared Traditional

K162319 - BabyDance Fertility Lubricant (FDA 510(k) Clearance)

K162319 · Fairhaven Health, LLC · Obstetrics & Gynecology device
Apr 2017
Decision
252d
Days
Class 2
Risk

K162319 is an FDA 510(k) clearance for the BabyDance Fertility Lubricant. This device is classified as a Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (Class II - Special Controls, product code PEB).

Submitted by Fairhaven Health, LLC (Bellingham, US). The FDA issued a Cleared decision on April 28, 2017, 252 days after receiving the submission on August 19, 2016.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. 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..

Submission Details

510(k) Number K162319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date April 28, 2017
Days to Decision 252 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PEB - Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.5300
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.