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FDA 510(k)

ASTROGLIDE

K-Number: K935299 · 1994-02-18

ApplicantBiofilm, Inc.
Decision Date1994-02-18
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASTROGLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 1994-02-18 under 510(k) number K935299. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTROGLIDE?

ASTROGLIDE is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Biofilm, Inc.. The 510(k) number is K935299.

When did ASTROGLIDE receive FDA 510(k) clearance?

ASTROGLIDE received FDA 510(k) clearance on 1994-02-18, under 510(k) number K935299.

Who is the listed applicant for ASTROGLIDE?

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?

The FDA product code for ASTROGLIDE is KMJ.

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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.

K221036Astroglide WarmingK220355Astroglide Ultra Gentle GelK220653Astroglide Glycerin & Paraben FreeK213671Astroglide Sensual Strawberry Personal LubricantK210242Astroglide X Silicone Personal LubricantK200239Astroglide Organix Gel

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Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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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