K203377 is an FDA 510(k) clearance for the VR101 Lubricating Intravaginal Ring. This device is classified as a Personal Lubricant Ring (Class II - Special Controls, product code QPD).
Submitted by J3 Bioscience, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 20, 2021, 184 days after receiving the submission on November 17, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. This Device Is A Personal Lubricant, For 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, Polyurethane, And/or Internal Condoms..
| 510(k) Number | K203377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2020 |
| Decision Date | May 20, 2021 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | QPD - Personal Lubricant Ring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
| Definition | This Device Is A Personal Lubricant, For 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, Polyurethane, And/or Internal Condoms. |