Astroglide Warming
K-Number: K221036 · 2022-07-01
ApplicantBiofilm, Inc.
Decision Date2022-07-01
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Astroglide Warming is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2022-07-01 under approval number K221036. 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 Warming?
Astroglide Warming is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Biofilm, Inc.. The 510(k) number is K221036.
When was Astroglide Warming approved by the FDA?
Astroglide Warming received FDA 510(k) clearance on 2022-07-01, under approval number K221036.
What company makes Astroglide Warming?
Astroglide Warming is manufactured by Biofilm, Inc..
What is the FDA product code for Astroglide Warming?
The FDA product code for Astroglide Warming 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.