K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
FDA 510(k) K143511 · Reckitt Benckiser
510(k) numberK143511
Submission
- Device name
- K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
- Applicant
- Reckitt Benckiser
Parsippany, NJ, US - Received
- December 11, 2014
- Decision date
- May 20, 2015
- 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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Questions and answers
When was K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant cleared by the FDA?
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant (K143511) received a 510(k) decision of Substantially Equivalent on May 20, 2015, 160 days after the submission was received.
What is the product code of K143511?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.