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FDA 510(k)

HERNIA MESH INTRODUCTION SYSTEM

K-Number: K945060 · 1995-03-02

ApplicantGerard Medical, Inc.
Decision Date1995-03-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HERNIA MESH INTRODUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gerard Medical, Inc.. It received FDA 510(k) clearance on 1995-03-02 under 510(k) number K945060. 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 HERNIA MESH INTRODUCTION SYSTEM?

HERNIA MESH INTRODUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is Gerard Medical, Inc.. The 510(k) number is K945060.

When did HERNIA MESH INTRODUCTION SYSTEM receive FDA 510(k) clearance?

HERNIA MESH INTRODUCTION SYSTEM received FDA 510(k) clearance on 1995-03-02, under 510(k) number K945060.

Who is the listed applicant for HERNIA MESH INTRODUCTION SYSTEM?

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

What is the FDA product code for HERNIA MESH INTRODUCTION SYSTEM?

The FDA product code for HERNIA MESH INTRODUCTION SYSTEM is FTL.

Related Clinical Trials

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Other records listing Gerard 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.

K974533TRIMPORTK972555CATHETER TUNNELERK936207ENDO-NEEDLE INSTRUMENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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