pjur WOMAN Nude pjur med SENSITIVE glide— 510(k) K200730

Substantially Equivalent

Pjur Group Luxembourg S.A.

FDA 510(k) clearance K200730 for pjur WOMAN Nude pjur med SENSITIVE glide, Substantially Equivalent on 2020-12-17. Applicant: Pjur Group Luxembourg S.A..

Clearance details

Applicant: Pjur Group Luxembourg S.A.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2020-03-20
Decision date: 2020-12-17
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.