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FDA 510(k)

The Sex Gel

K-Number: K181078 · 2018-09-10

ApplicantNecessaire, Inc.
Decision Date2018-09-10
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

The Sex Gel is a medical device manufactured by Necessaire, Inc.. It received FDA 510(k) clearance on 2018-09-10 under approval number K181078. 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 The Sex Gel?

The Sex Gel is a medical device that received FDA 510(k) clearance on 2018-09-10. It is manufactured by Necessaire, Inc.. The 510(k) number is K181078.

When was The Sex Gel approved by the FDA?

The Sex Gel received FDA 510(k) clearance on 2018-09-10, under approval number K181078.

What company makes The Sex Gel?

The Sex Gel is manufactured by Necessaire, Inc..

What is the FDA product code for The Sex Gel?

The FDA product code for The Sex Gel 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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