Water-based lubricant— 510(k) K253983

Substantially Equivalent

Guangzhou Haoyimai Trading Co., Ltd.

FDA 510(k) clearance K253983 for Water-based lubricant, Substantially Equivalent on 2026-03-06. Applicant: Guangzhou Haoyimai Trading Co., Ltd..

Clearance details

Applicant: Guangzhou Haoyimai Trading Co., Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-12
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, 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.