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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 a medical device manufactured by United Consortium. It received FDA 510(k) clearance on 2018-04-09 under approval 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. It is manufactured by United Consortium. The 510(k) number is K180083.

When was Silicone Personal Lubricant, ALL-IN-ONE approved by the FDA?

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

What company makes Silicone Personal Lubricant, ALL-IN-ONE?

Silicone Personal Lubricant, ALL-IN-ONE is manufactured by United Consortium.

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.

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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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