Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant +3 more— 510(k) K251773

Name: FDA 510(k) clearance K251773
Creator: U.S. Food and Drug Administration
Published: 2025-09-09

Substantially Equivalent

Shenzhen Yongquan Medical Devices Co., Ltd.

FDA 510(k) clearance K251773 for Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant +3 more, Substantially Equivalent on 2025-09-09. Applicant: Shenzhen Yongquan Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
Applicant: Shenzhen Yongquan Medical Devices Co., Ltd.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2025-06-10
Decision date: 2025-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.