Internal Hydrating Gel
FDA 510(k) K141718 · Combe Incorporated
510(k) numberK141718
Submission
- Device name
- Internal Hydrating Gel
- Applicant
- Combe Incorporated
White Plains, NY, US - Received
- June 25, 2014
- Decision date
- November 13, 2014
- 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 Internal Hydrating Gel cleared by the FDA?
Internal Hydrating Gel (K141718) received a 510(k) decision of Substantially Equivalent on November 13, 2014, 141 days after the submission was received.
What is the product code of K141718?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.