K-Y Marilyn Pleasure Gel
FDA 510(k) K151884 · Reckitt Benckiser, LLC
510(k) numberK151884
Submission
- Device name
- K-Y Marilyn Pleasure Gel
- Applicant
- Reckitt Benckiser, LLC
Parsippany, NJ, US - Received
- July 9, 2015
- Decision date
- January 11, 2016
- 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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| K173504 | K-Y SiliconeNUC · Traditional | 01/12/2018SE |
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| K131643 | Durex Realfeel Pleasure Gel Personal LubricantNUC · Traditional | 12/17/2014SE |
| K140193 | Durex Embrace Personal LubricantNUC · Traditional | 11/04/2014SE |
| K990703 | Sporox II Sterilizing & Disinfecting SolutionMED · Special | 03/30/1999SE |
| K970230 | SporoxMED · Traditional | 10/29/1997SE |
| K963353 | Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46)LRJ · Traditional | 10/18/1996SE |
Questions and answers
When was K-Y Marilyn Pleasure Gel cleared by the FDA?
K-Y Marilyn Pleasure Gel (K151884) received a 510(k) decision of Substantially Equivalent on January 11, 2016, 186 days after the submission was received.
What is the product code of K151884?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.