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.)— 510(k) K251773

Substantially Equivalent

Shenzhen Yongquan Medical Devices Co., Ltd.

FDA 510(k) clearance K251773 for 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.), Substantially Equivalent on 2025-09-09. Applicant: Shenzhen Yongquan Medical Devices Co., Ltd..

Clearance details

Applicant: Shenzhen Yongquan Medical Devices Co., Ltd.
Product code: Code NUC
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 ↗

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.