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FDA 510(k)

STERIGAUZE GEL DRESSING

K-Number: K952419 · 1995-07-26

ApplicantAcacia Laboratories, Inc.
Decision Date1995-07-26
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

STERIGAUZE GEL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Acacia Laboratories, Inc.. It received FDA 510(k) clearance on 1995-07-26 under 510(k) number K952419. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERIGAUZE GEL DRESSING?

STERIGAUZE GEL DRESSING is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Acacia Laboratories, Inc.. The 510(k) number is K952419.

When did STERIGAUZE GEL DRESSING receive FDA 510(k) clearance?

STERIGAUZE GEL DRESSING received FDA 510(k) clearance on 1995-07-26, under 510(k) number K952419.

Who is the listed applicant for STERIGAUZE GEL DRESSING?

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

What is the FDA product code for STERIGAUZE GEL DRESSING?

The FDA product code for STERIGAUZE GEL DRESSING is MGQ.

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Other records listing Acacia Laboratories, 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.

K952420STERIGAUZE WET DRESSINGK951861STERICARE WOUND CARE GELK952414PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETERK951914HYDRACARE ABSORBENT WOUND DRESSINGK950344HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETERK913408STERILE PLASTIC DRAPE

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Related Devices (Code: MGQ)

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.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET ACTIVEMedline Industries, Inc.

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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