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FDA 510(k)

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

K-Number: K030460 · 2003-03-07

ApplicantBrennen Medical, Inc.
Decision Date2003-03-07
Product CodePAG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX 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 2003-03-07 under 510(k) number K030460. The device is classified under product code PAG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX?

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX is a medical device that received FDA 510(k) clearance on 2003-03-07. The listed applicant is Brennen Medical, Inc.. The 510(k) number is K030460.

When did MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX receive FDA 510(k) clearance?

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX received FDA 510(k) clearance on 2003-03-07, under 510(k) number K030460.

Who is the listed applicant for MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX?

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 MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX?

The FDA product code for MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX is PAG.

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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 DRESSINGK021835BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEXK002078BETA GLUCAN GEL (MACROPRO GEL)K002077GLUCANPRO CREAMK000518MACROPRO GELK000519GLUCANPRO

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Related Devices (Code: PAG)

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.

K090688COOK UROLOGICAL GRAFTCook Biotech, Inc.K050445AMS COLLAGEN DERMAL MATRIXAmerican Medical Systems, Inc.K042949PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)C.R. Bard, Inc.K031295BARD INNERLACE BIOURETHRAL SUPPORT SYSTEMC.R. Bard, Inc.K020654STRATASIS SLING KITCook Biotech, Inc.K993459MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXAdvanced Uroscience, 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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