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

FDA 510(k)

BETA GLUCAN GEL (MACROPRO GEL)

K-Number: K002078 · 2000-10-02

ApplicantBrennen Medical, Inc.
Decision Date2000-10-02
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

BETA GLUCAN GEL (MACROPRO GEL) is the device name listed in this FDA 510(k) record. The listed applicant is Brennen Medical, Inc.. It received FDA 510(k) clearance on 2000-10-02 under 510(k) number K002078. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA GLUCAN GEL (MACROPRO GEL)?

BETA GLUCAN GEL (MACROPRO GEL) is a medical device that received FDA 510(k) clearance on 2000-10-02. The listed applicant is Brennen Medical, Inc.. The 510(k) number is K002078.

When did BETA GLUCAN GEL (MACROPRO GEL) receive FDA 510(k) clearance?

BETA GLUCAN GEL (MACROPRO GEL) received FDA 510(k) clearance on 2000-10-02, under 510(k) number K002078.

Who is the listed applicant for BETA GLUCAN GEL (MACROPRO GEL)?

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

What is the FDA product code for BETA GLUCAN GEL (MACROPRO GEL)?

The FDA product code for BETA GLUCAN GEL (MACROPRO GEL) is MGQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Brennen Medical, 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.

K050086BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSINGK030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXK021835BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEXK002077GLUCANPRO CREAMK000519GLUCANPROK000518MACROPRO GEL

View all 17 devices →

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.

↑