K-Y Brand Warming Liquid
FDA 510(k) K070545 · Personal Products Co.
510(k) numberK070545
Submission
- Device name
- K-Y Brand Warming Liquid
- Applicant
- Personal Products Co.
Skillman, NJ, US - Received
- February 26, 2007
- Decision date
- March 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K062796 | K-Y Brand IntrigueNUC · Traditional | 12/08/2006SE |
| K010365 | Ortho Control Female Urinary Control DeviceMNG · Traditional | 04/30/2001SE |
| K990536 | O.B. TamponHEB · Traditional | 08/31/1999SE |
| K991118 | O.B. Applicator Tampons, O.B. TamponsHEB · Traditional | 06/29/1999SE |
| K974629 | O.B. Applicator and Non-Applicator TamponsHEB · Traditional | 02/10/1998SE |
| K971589 | Reach Antibacterial ToothbrushEFW · Traditional | 07/24/1997SE |
| K970954 | O.B. Applicator TamponsHEB · Traditional | 06/10/1997SE |
| K961119 | Carefree PantylinersHHL · Traditional | 04/17/1996SE |
| K953638 | O.B. Applicator TamponsHIL · Traditional | 10/20/1995SE |
| K941863 | O.B. TamponHEB · Traditional | 06/27/1994SE |
Questions and answers
When was K-Y Brand Warming Liquid cleared by the FDA?
K-Y Brand Warming Liquid (K070545) received a 510(k) decision of Substantially Equivalent on March 23, 2007, 25 days after the submission was received.
What is the product code of K070545?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.