510(k) K183505
K183505 is an FDA 510(k) premarket notification submitted by Rb Health (Us), LLC for the device "KY Banksy Moisture". The FDA issued a decision of Substantially Equivalent on May 17, 2019. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Rb Health (Us), LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2019
- Date Received
- December 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Personal
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
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.