KY Grosz UltraGel
FDA 510(k) K192982 · Rb Health (Us), LLC
510(k) numberK192982
Submission
- Device name
- KY Grosz UltraGel
- Applicant
- Rb Health (Us), LLC
Parsippany, NJ, US - Received
- October 25, 2019
- Decision date
- April 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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.
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| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K241617 | Durex Polyisoprene CondomMOL · Traditional | 02/28/2025SE |
| K230781 | Belle SensilubeNUC · Traditional | 06/20/2023SE |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineNUC · Traditional | 03/07/2023SE |
| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | 11/07/2022SE |
| K222068 | Durex Penck III RegularHIS · Traditional | 10/12/2022SE |
| K211152 | Durex Condom with BenzocaineHIS · Traditional | 05/11/2022SE |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play…NUC · Traditional | 03/01/2022SE |
| K213647 | Durex Patronus WideHIS · Traditional | 02/17/2022SE |
| K211088 | Grosz Play FeelNUC · Traditional | 07/09/2021SE |
| K200672 | Durex Penck Standard, Durex Penck XLHIS · Traditional | 11/06/2020SE |
Questions and answers
When was KY Grosz UltraGel cleared by the FDA?
KY Grosz UltraGel (K192982) received a 510(k) decision of Substantially Equivalent on April 14, 2020, 172 days after the submission was received.
What is the product code of K192982?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.