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)

PROLEX MESH

K-Number: K960219 · 1996-03-15

ApplicantAdvanced Surgical Innovations, Inc.
Decision Date1996-03-15
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROLEX MESH is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Innovations, Inc.. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K960219. 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 PROLEX MESH?

PROLEX MESH is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Advanced Surgical Innovations, Inc.. The 510(k) number is K960219.

When did PROLEX MESH receive FDA 510(k) clearance?

PROLEX MESH received FDA 510(k) clearance on 1996-03-15, under 510(k) number K960219.

Who is the listed applicant for PROLEX MESH?

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

What is the FDA product code for PROLEX MESH?

The FDA product code for PROLEX MESH is FTL.

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

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.

↑