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FDA 510(k)

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

K-Number: K191480 · 2019-10-11

ApplicantTrigg Laboratories, Inc. D/B/A Wet International
Decision Date2019-10-11
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a medical device manufactured by Trigg Laboratories, Inc. D/B/A Wet International. It received FDA 510(k) clearance on 2019-10-11 under approval number K191480. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)?

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Trigg Laboratories, Inc. D/B/A Wet International. The 510(k) number is K191480.

When was Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) approved by the FDA?

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) received FDA 510(k) clearance on 2019-10-11, under approval number K191480.

What company makes Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)?

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is manufactured by Trigg Laboratories, Inc. D/B/A Wet International.

What is the FDA product code for Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)?

The FDA product code for Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is NUC.

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Related PubMed Literature

PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025) PMID: 40060767 Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation. Bioengineering & translational medicine (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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