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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 the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2019-04-17 under 510(k) 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. The listed applicant is United Consortium. The 510(k) number is K183584.

When did JO H2O Jelly Original Personal Lubricant receive FDA 510(k) clearance?

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

Who is the listed applicant for JO H2O Jelly Original Personal Lubricant?

The FDA 510(k) record lists United Consortium as the applicant. This does not by itself establish the device manufacturer.

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 records listing United Consortium as applicant

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.

K192203JO for Him H2O Gel Original Personal LubricantK190858Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal LubricantK191214JO Premium Jelly Original Personal LubricantK182585JO Actively Trying Personal LubricantK183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal LubricantK182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant

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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.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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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