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 a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2020-10-13 under approval 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. It is manufactured by Biofilm, Inc.. The 510(k) number is K200114.
When was Astroglide Organix Liquid approved by the FDA?
Astroglide Organix Liquid received FDA 510(k) clearance on 2020-10-13, under approval number K200114.
What company makes Astroglide Organix Liquid?
Astroglide Organix Liquid is manufactured by Biofilm, Inc..
What is the FDA product code for Astroglide Organix Liquid?
The FDA product code for Astroglide Organix Liquid is 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.