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)

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

K-Number: K993459 · 1999-11-05

ApplicantAdvanced Uroscience, Inc.
Decision Date1999-11-05
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 Advanced Uroscience, Inc.. It received FDA 510(k) clearance on 1999-11-05 under 510(k) number K993459. 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 1999-11-05. The listed applicant is Advanced Uroscience, Inc.. The 510(k) number is K993459.

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 1999-11-05, under 510(k) number K993459.

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

The FDA 510(k) record lists Advanced Uroscience, 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.

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 Advanced Uroscience, 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.

K001807TISSUE MARKERK002573ADVANCED UROSCIENCE INNERSHEATHK002323ADVANCED UROSCIENCE INJECTION NEEDLEK982890ADVANCED UROSCIENCE INJECTION NEEDLE

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.K030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXBrennen Medical, Inc.K020654STRATASIS SLING KITCook Biotech, 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.

↑