Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Astroglide Sensual Strawberry Personal Lubricant

K-Number: K213671 · 2022-03-03

ApplicantBiofilm, Inc.
Decision Date2022-03-03
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide Sensual Strawberry Personal Lubricant is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2022-03-03 under approval number K213671. 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 Sensual Strawberry Personal Lubricant?

Astroglide Sensual Strawberry Personal Lubricant is a medical device that received FDA 510(k) clearance on 2022-03-03. It is manufactured by Biofilm, Inc.. The 510(k) number is K213671.

When was Astroglide Sensual Strawberry Personal Lubricant approved by the FDA?

Astroglide Sensual Strawberry Personal Lubricant received FDA 510(k) clearance on 2022-03-03, under approval number K213671.

What company makes Astroglide Sensual Strawberry Personal Lubricant?

Astroglide Sensual Strawberry Personal Lubricant is manufactured by Biofilm, Inc..

What is the FDA product code for Astroglide Sensual Strawberry Personal Lubricant?

The FDA product code for Astroglide Sensual Strawberry Personal Lubricant is NUC.

Other Devices by Biofilm, Inc.

K171985Astroglide O Oil Personal Lubricant & Massage Oil K163395Astroglide Diamond Silicone Gel Personal Lubricant K200239Astroglide Organix Gel K200114Astroglide Organix Liquid K210242Astroglide X Silicone Personal Lubricant K221036Astroglide Warming

View all 9 devices →

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.

↑