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FDA 510(k)

Astroglide Diamond Silicone Gel Personal Lubricant

K-Number: K163395 · 2017-02-10

ApplicantBiofilm, Inc.
Decision Date2017-02-10
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide Diamond Silicone Gel Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K163395. 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 Diamond Silicone Gel Personal Lubricant?

Astroglide Diamond Silicone Gel Personal Lubricant is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Biofilm, Inc.. The 510(k) number is K163395.

When did Astroglide Diamond Silicone Gel Personal Lubricant receive FDA 510(k) clearance?

Astroglide Diamond Silicone Gel Personal Lubricant received FDA 510(k) clearance on 2017-02-10, under 510(k) number K163395.

Who is the listed applicant for Astroglide Diamond Silicone Gel Personal Lubricant?

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 Diamond Silicone Gel Personal Lubricant?

The FDA product code for Astroglide Diamond Silicone Gel Personal Lubricant is NUC.

Other records listing Biofilm, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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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