PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE— 510(k) K133233
Substantially EquivalentPjur Group Luxembourg S.A.
FDA 510(k) clearance K133233 for PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE, Substantially Equivalent on 2014-07-18. Applicant: Pjur Group Luxembourg S.A.. Device class: 2.
Clearance details
- Applicant
- Pjur Group Luxembourg S.A.
- Product code
- Code NUC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, NC, US
Recent devices under product code NUC
view allMore clearances from Pjur Group Luxembourg S.A.
view all- K260068 — pjur NATURE Touch, 100 ml
- K200527 — pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
- K200731 — pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
- K200730 — pjur WOMAN Nude pjur med SENSITIVE glide
- K141913 — PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
Adverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.