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— 510(k) K200527
Substantially EquivalentPjur Group Luxembourg S.A.
FDA 510(k) clearance K200527 for 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, Substantially Equivalent on 2021-02-19. 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
- Wasserbillig, LU
Recent devices under product code NUC
view allMore clearances from Pjur Group Luxembourg S.A.
view all- K260068 — pjur NATURE Touch, 100 ml
- 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!
- K133336 — PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
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.