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FDA 510(k)

TYRX SURGICAL MESH, MODEL SMPC-0501

K-Number: K052864 · 2005-12-22

ApplicantTyrx Pharma, Inc.
Decision Date2005-12-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TYRX SURGICAL MESH, MODEL SMPC-0501 is the device name listed in this FDA 510(k) record. The listed applicant is Tyrx Pharma, Inc.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K052864. 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 TYRX SURGICAL MESH, MODEL SMPC-0501?

TYRX SURGICAL MESH, MODEL SMPC-0501 is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Tyrx Pharma, Inc.. The 510(k) number is K052864.

When did TYRX SURGICAL MESH, MODEL SMPC-0501 receive FDA 510(k) clearance?

TYRX SURGICAL MESH, MODEL SMPC-0501 received FDA 510(k) clearance on 2005-12-22, under 510(k) number K052864.

Who is the listed applicant for TYRX SURGICAL MESH, MODEL SMPC-0501?

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

What is the FDA product code for TYRX SURGICAL MESH, MODEL SMPC-0501?

The FDA product code for TYRX SURGICAL MESH, MODEL SMPC-0501 is FTL.

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Other records listing Tyrx Pharma, 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.

K063091PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601K053656TYRX ANTIMICROBIAL MESH

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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