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FDA 510(k)

K-Y Silicone

K-Number: K173504 · 2018-01-12

ApplicantReckitt Benckiser, LLC
Decision Date2018-01-12
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

K-Y Silicone is the device name listed in this FDA 510(k) record. The listed applicant is Reckitt Benckiser, LLC. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K173504. 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 K-Y Silicone?

K-Y Silicone is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Reckitt Benckiser, LLC. The 510(k) number is K173504.

When did K-Y Silicone receive FDA 510(k) clearance?

K-Y Silicone received FDA 510(k) clearance on 2018-01-12, under 510(k) number K173504.

Who is the listed applicant for K-Y Silicone?

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

What is the FDA product code for K-Y Silicone?

The FDA product code for K-Y Silicone is NUC.

Other records listing Reckitt Benckiser, LLC 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.

K151884K-Y Marilyn Pleasure Gel

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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