510(k) K203377
- Device
- VR101 Lubricating Intravaginal Ring
- Applicant
- J3 Bioscience, Inc.
- 510(k) number
- K203377
- Product code
- NUC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-20
- Date received
- 2020-11-17
- Regulation
- 884.5300
- Classification name
- Lubricant, Personal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- R. Tyler McCabe
- Address
- 825 N. 300 W., Suite N231 Salt Lake City UT US 84103 84103
FDA Registration Numbers#
- 3021574111
- 3012758946
Source Documents#
Other 510(k) Records For Product Code NUC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260117 | Everslide | Special Situations, LLC | 2026-09-23 |
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | Maxigen Biotech, Inc. | 2026-09-03 |
| K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | 2026-07-09 |
| K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | 2026-07-06 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | 2026-06-22 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | 2026-06-11 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | 2026-06-09 |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | 2026-05-21 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026-04-16 |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | 2026-04-01 |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | 2026-03-06 |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | 2025-12-19 |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | 2025-12-12 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases