510(k) K252914— Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

Substantially Equivalent

Hathor Professional Skincare , Ltd.

Clearance details

Applicant: Hathor Professional Skincare , Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2025-09-12
Decision date: 2026-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, CA

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.