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FDA 510(k)

LUVENA VAGINAL MOISTURIZER & LUBRICANT

K-Number: K162235 · 2017-03-24

ApplicantLaclede, Inc.
Decision Date2017-03-24
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LUVENA VAGINAL MOISTURIZER & LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Laclede, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162235. 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 LUVENA VAGINAL MOISTURIZER & LUBRICANT?

LUVENA VAGINAL MOISTURIZER & LUBRICANT is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Laclede, Inc.. The 510(k) number is K162235.

When did LUVENA VAGINAL MOISTURIZER & LUBRICANT receive FDA 510(k) clearance?

LUVENA VAGINAL MOISTURIZER & LUBRICANT received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162235.

Who is the listed applicant for LUVENA VAGINAL MOISTURIZER & LUBRICANT?

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

What is the FDA product code for LUVENA VAGINAL MOISTURIZER & LUBRICANT?

The FDA product code for LUVENA VAGINAL MOISTURIZER & LUBRICANT is NUC.

Other records listing Laclede, Inc. as applicant

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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