Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)— 510(k) K191480

Name: FDA 510(k) clearance K191480
Creator: U.S. Food and Drug Administration
Published: 2019-10-11

Substantially Equivalent

Trigg Laboratories, Inc. D/B/A Wet International

FDA 510(k) clearance K191480 for Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid), Substantially Equivalent on 2019-10-11. Applicant: Trigg Laboratories, Inc. D/B/A Wet International. Device class: 2.

Clearance details

Applicant: Trigg Laboratories, Inc. D/B/A Wet International
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2019-06-04
Decision date: 2019-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, CA, US

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.