Astroglide Organix Gel
K-Number: K200239 · 2020-11-13
ApplicantBiofilm, Inc.
Decision Date2020-11-13
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Astroglide Organix Gel is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2020-11-13 under approval number K200239. 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 Gel?
Astroglide Organix Gel is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Biofilm, Inc.. The 510(k) number is K200239.
When was Astroglide Organix Gel approved by the FDA?
Astroglide Organix Gel received FDA 510(k) clearance on 2020-11-13, under approval number K200239.
What company makes Astroglide Organix Gel?
Astroglide Organix Gel is manufactured by Biofilm, Inc..
What is the FDA product code for Astroglide Organix Gel?
The FDA product code for Astroglide Organix Gel 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.