Cleared Traditional

BabyDance Fertility Lubricant

K162319 · Fairhaven Health, LLC · Obstetrics & Gynecology

Apr 2017

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K162319 is an FDA 510(k) clearance for the BabyDance Fertility Lubricant, 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 review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K162319 FDA.gov
FDA Decision	Cleared 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.