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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Biofilm, Inc.. The 510(k) number is K221036.

When did Astroglide Warming receive FDA 510(k) clearance?

Astroglide Warming received FDA 510(k) clearance on 2022-07-01, under 510(k) number K221036.

Who is the listed applicant for Astroglide Warming?

The FDA 510(k) record lists Biofilm, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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