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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

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 the device name listed in this FDA 510(k) record. The listed applicant is Trigg Laboratories, Inc. D/B/A Wet International. It received FDA 510(k) clearance on 2019-10-11 under 510(k) 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. The listed applicant is Trigg Laboratories, Inc. D/B/A Wet International. The 510(k) number is K191480.

When did Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) receive FDA 510(k) clearance?

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 510(k) number K191480.

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

The FDA 510(k) record lists Trigg Laboratories, Inc. D/B/A Wet International as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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