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

Name: FDA 510(k) clearance K252914
Creator: U.S. Food and Drug Administration
Published: 2026-06-09

Substantially Equivalent

Hathor Professional Skincare , Ltd.

FDA 510(k) clearance K252914 for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147), Substantially Equivalent on 2026-06-09. Applicant: Hathor Professional Skincare , Ltd.. Device class: 2.

Clearance details

Applicant: Hathor Professional Skincare , Ltd.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2025-09-12
Decision date: 2026-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, CA

Download summary PDF View on FDA.gov ↗

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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.