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FDA 510(k)

BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX

K-Number: K021835 · 2002-10-17

ApplicantBrennen Medical, Inc.
Decision Date2002-10-17
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX 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 2002-10-17 under 510(k) number K021835. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX?

BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX is a medical device that received FDA 510(k) clearance on 2002-10-17. The listed applicant is Brennen Medical, Inc.. The 510(k) number is K021835.

When did BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX receive FDA 510(k) clearance?

BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX received FDA 510(k) clearance on 2002-10-17, under 510(k) number K021835.

Who is the listed applicant for BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX?

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 BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX?

The FDA product code for BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX is FTL.

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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 MATRIXK002078BETA GLUCAN GEL (MACROPRO GEL)K002077GLUCANPRO CREAMK000518MACROPRO GELK000519GLUCANPRO

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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