Pjur Original, Pjur Woman, Pjur Man Extreme Glide
FDA 510(k) K133233 · Pjur Group Luxembourg S.A.
510(k) numberK133233
Submission
- Device name
- Pjur Original, Pjur Woman, Pjur Man Extreme Glide
- Applicant
- Pjur Group Luxembourg S.A.
Wilmington, NC, US - Received
- October 21, 2013
- Decision date
- July 18, 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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| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | 05/21/2026SE |
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| K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal…NUC · Traditional | 01/21/2021SE |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glideNUC · Traditional | 12/17/2020SE |
| K141913 | Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse Me!NUC · Traditional | 04/06/2015SE |
| K133336 | Pjur(R) Siliconegel, Pjur(R) Basic Personal Glide, Pjur(R) Light, Pjur(R) Med Premium…NUC · Traditional | 07/24/2014SE |
Questions and answers
When was Pjur Original, Pjur Woman, Pjur Man Extreme Glide cleared by the FDA?
Pjur Original, Pjur Woman, Pjur Man Extreme Glide (K133233) received a 510(k) decision of Substantially Equivalent on July 18, 2014, 270 days after the submission was received.
What is the product code of K133233?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.