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FDA 510(k)

Silicone Personal Lubricant, ALL-IN-ONE

K-Number: K180083 · 2018-04-09

ApplicantUnited Consortium
Decision Date2018-04-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Silicone Personal Lubricant, ALL-IN-ONE is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2018-04-09 under 510(k) number K180083. 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 Silicone Personal Lubricant, ALL-IN-ONE?

Silicone Personal Lubricant, ALL-IN-ONE is a medical device that received FDA 510(k) clearance on 2018-04-09. The listed applicant is United Consortium. The 510(k) number is K180083.

When did Silicone Personal Lubricant, ALL-IN-ONE receive FDA 510(k) clearance?

Silicone Personal Lubricant, ALL-IN-ONE received FDA 510(k) clearance on 2018-04-09, under 510(k) number K180083.

Who is the listed applicant for Silicone Personal Lubricant, ALL-IN-ONE?

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 Silicone Personal Lubricant, ALL-IN-ONE?

The FDA product code for Silicone Personal Lubricant, ALL-IN-ONE 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.

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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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