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FDA 510(k)

Astroglide X Silicone Personal Lubricant

K-Number: K210242 · 2021-04-28

ApplicantBiofilm, Inc.
Decision Date2021-04-28
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide X Silicone Personal Lubricant is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2021-04-28 under approval number K210242. 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 X Silicone Personal Lubricant?

Astroglide X Silicone Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Biofilm, Inc.. The 510(k) number is K210242.

When was Astroglide X Silicone Personal Lubricant approved by the FDA?

Astroglide X Silicone Personal Lubricant received FDA 510(k) clearance on 2021-04-28, under approval number K210242.

What company makes Astroglide X Silicone Personal Lubricant?

Astroglide X Silicone Personal Lubricant is manufactured by Biofilm, Inc..

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

The FDA product code for Astroglide X Silicone 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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