Plum Vagiceuticals Vaginal Moisturizing Suppositories
FDA 510(k) K261909 · PCCA, Inc.
510(k) numberK261909
Submission
- Device name
- Plum Vagiceuticals Vaginal Moisturizing Suppositories
- Applicant
- PCCA, Inc.
Houston, TX, US - Received
- June 8, 2026
- Decision date
- July 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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.
Other 510(k)s with product code NUC
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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 |
| 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 |
| K253983 | Water-based lubricantNUC · Traditional | Guangzhou Haoyimai Trading Co., Ltd. | 03/06/2026SE |
More from Guangzhou Haoyimai Trading Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K203091 | MucoLock Oral GelOLR · Traditional | 02/12/2021SE |
Questions and answers
When was Plum Vagiceuticals Vaginal Moisturizing Suppositories cleared by the FDA?
Plum Vagiceuticals Vaginal Moisturizing Suppositories (K261909) received a 510(k) decision of Substantially Equivalent on July 6, 2026, 28 days after the submission was received.
What is the product code of K261909?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.