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FDA 510(k)

Astroglide Diamond Silicone Gel Personal Lubricant

K-Number: K163395 · 2017-02-10

ApplicantBiofilm, Inc.
Decision Date2017-02-10
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide Diamond Silicone Gel Personal Lubricant is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2017-02-10 under approval number K163395. 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 Astroglide Diamond Silicone Gel Personal Lubricant?

Astroglide Diamond Silicone Gel Personal Lubricant is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Biofilm, Inc.. The 510(k) number is K163395.

When was Astroglide Diamond Silicone Gel Personal Lubricant approved by the FDA?

Astroglide Diamond Silicone Gel Personal Lubricant received FDA 510(k) clearance on 2017-02-10, under approval number K163395.

What company makes Astroglide Diamond Silicone Gel Personal Lubricant?

Astroglide Diamond Silicone Gel Personal Lubricant is manufactured by Biofilm, Inc..

What is the FDA product code for Astroglide Diamond Silicone Gel Personal Lubricant?

The FDA product code for Astroglide Diamond Silicone Gel Personal Lubricant is NUC.

Other Devices by Biofilm, Inc.

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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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