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FDA 510(k)

JO H2O Jelly Original Personal Lubricant

K-Number: K183584 · 2019-04-17

ApplicantUnited Consortium
Decision Date2019-04-17
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JO H2O Jelly Original Personal Lubricant is a medical device manufactured by United Consortium. It received FDA 510(k) clearance on 2019-04-17 under approval number K183584. 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 H2O Jelly Original Personal Lubricant?

JO H2O Jelly Original Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by United Consortium. The 510(k) number is K183584.

When was JO H2O Jelly Original Personal Lubricant approved by the FDA?

JO H2O Jelly Original Personal Lubricant received FDA 510(k) clearance on 2019-04-17, under approval number K183584.

What company makes JO H2O Jelly Original Personal Lubricant?

JO H2O Jelly Original Personal Lubricant is manufactured by United Consortium.

What is the FDA product code for JO H2O Jelly Original Personal Lubricant?

The FDA product code for JO H2O Jelly Original Personal Lubricant is NUC.

Other Devices by United Consortium

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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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