K193450 is an FDA 510(k) clearance for the Pre-Seed? Fertility Lubricant, 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 review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K193450 FDA.gov |
| FDA Decision | Cleared 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 |
| 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. |