Cleared Traditional

K193450 - Pre-Seed™ Fertility Lubricant (FDA 510(k) Clearance)

K193450 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Jul 2020
Decision
223d
Days
Class 2
Risk

K193450 is an FDA 510(k) clearance for the Pre-Seed™ Fertility Lubricant. This device is classified as a Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (Class II - Special Controls, product code PEB).

Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on July 23, 2020, 223 days after receiving the submission on December 13, 2019.

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 K193450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2019
Decision Date July 23, 2020
Days to Decision 223 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.