K062796 is an FDA 510(k) clearance for the K-Y BRAND INTRIGUE, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on December 8, 2006, 80 days after receiving the submission on September 19, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K062796 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2006 |
| Decision Date | December 08, 2006 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NUC — Lubricant, Personal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
| Definition | This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. |