Trojan Crystal Clear Liquid
FDA 510(k) K013614 · Armkel, LLC
510(k) numberK013614
Submission
- Device name
- Trojan Crystal Clear Liquid
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- November 5, 2001
- Decision date
- February 1, 2002
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | 10/19/2004SE |
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| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
| K963318 | Legionella Igg/Igm Elisa Test SystemLHL · Traditional | 03/03/1997SE |
Questions and answers
When was Trojan Crystal Clear Liquid cleared by the FDA?
Trojan Crystal Clear Liquid (K013614) received a 510(k) decision of Substantially Equivalent on February 1, 2002, 88 days after the submission was received.
What is the product code of K013614?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.