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FDA 510(k)

JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant

K-Number: K183384 · 2019-03-04

ApplicantUnited Consortium
Decision Date2019-03-04
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant is a medical device manufactured by United Consortium. It received FDA 510(k) clearance on 2019-03-04 under approval number K183384. 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 JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant?

JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant is a medical device that received FDA 510(k) clearance on 2019-03-04. It is manufactured by United Consortium. The 510(k) number is K183384.

When was JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant approved by the FDA?

JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant received FDA 510(k) clearance on 2019-03-04, under approval number K183384.

What company makes JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant?

JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant is manufactured by United Consortium.

What is the FDA product code for JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant?

The FDA product code for JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant 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: 41090443 Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023. Clinical trials (London, England) (2026) PMID: 40606638 Silent protocol modifications in multiple sclerosis clinical trials: a registry-based cross-sectional study. Therapeutic advances in neurological disorders (2025)

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Related Devices (Code: NUC)

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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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