Astroglide Ultra Gentle Gel
K-Number: K220355 · 2022-05-26
ApplicantBiofilm, Inc.
Decision Date2022-05-26
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Astroglide Ultra Gentle Gel is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2022-05-26 under approval number K220355. 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 Ultra Gentle Gel?
Astroglide Ultra Gentle Gel is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Biofilm, Inc.. The 510(k) number is K220355.
When was Astroglide Ultra Gentle Gel approved by the FDA?
Astroglide Ultra Gentle Gel received FDA 510(k) clearance on 2022-05-26, under approval number K220355.
What company makes Astroglide Ultra Gentle Gel?
Astroglide Ultra Gentle Gel is manufactured by Biofilm, Inc..
What is the FDA product code for Astroglide Ultra Gentle Gel?
The FDA product code for Astroglide Ultra Gentle Gel is NUC.
Other Devices by Biofilm, Inc.
Related Devices (Code: NUC)
K161585Mano and Mano Personal LubricantMano and Mano Proprietary Limited
K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc.
K161385Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products
K152671Pulse Aloe-ahhToaster Labs, Inc.
K152628Pulse H20h!Toaster Labs, Inc.
K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.
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.