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 Equivalent

Pjur 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..

Clearance details

Applicant: Pjur Group Luxembourg S.A.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2020-03-02
Decision date: 2021-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wasserbillig, LU

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.