510(k) K203377
K203377 is an FDA 510(k) premarket notification submitted by J3 Bioscience, Inc. for the device "VR101 Lubricating Intravaginal Ring". The FDA issued a decision of Substantially Equivalent on May 20, 2021. The device falls under product code QPD (Personal Lubricant Ring), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2021
- Date Received
- November 17, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Personal Lubricant Ring
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
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.