Pjur(R) Siliconegel, Pjur(R) Basic Personal Glide, Pjur(R) Light, Pjur(R) Med Premium Glide
FDA 510(k) K133336 · Pjur Group Luxembourg S.A.
510(k) numberK133336
Submission
- Device name
- Pjur(R) Siliconegel, Pjur(R) Basic Personal Glide, Pjur(R) Light, Pjur(R) Med Premium Glide
- Applicant
- Pjur Group Luxembourg S.A.
Wilmington, NC, US - Received
- October 29, 2013
- Decision date
- July 24, 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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| K141913 | Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse Me!NUC · Traditional | 04/06/2015SE |
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Questions and answers
When was Pjur(R) Siliconegel, Pjur(R) Basic Personal Glide, Pjur(R) Light, Pjur(R) Med Premium Glide cleared by the FDA?
Pjur(R) Siliconegel, Pjur(R) Basic Personal Glide, Pjur(R) Light, Pjur(R) Med Premium Glide (K133336) received a 510(k) decision of Substantially Equivalent on July 24, 2014, 268 days after the submission was received.
What is the product code of K133336?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.