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FDA 510(k)

Astroglide Organix Liquid

K-Number: K200114 · 2020-10-13

ApplicantBiofilm, Inc.
Decision Date2020-10-13
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide Organix Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2020-10-13 under 510(k) number K200114. 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 Organix Liquid?

Astroglide Organix Liquid is a medical device that received FDA 510(k) clearance on 2020-10-13. The listed applicant is Biofilm, Inc.. The 510(k) number is K200114.

When did Astroglide Organix Liquid receive FDA 510(k) clearance?

Astroglide Organix Liquid received FDA 510(k) clearance on 2020-10-13, under 510(k) number K200114.

Who is the listed applicant for Astroglide Organix Liquid?

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

What is the FDA product code for Astroglide Organix Liquid?

The FDA product code for Astroglide Organix Liquid is NUC.

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Related Devices (Code: 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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