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FDA 510(k)

REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH

K-Number: K023328 · 2002-12-12

ApplicantCenter For Biomaterials and Advanced Technologies
Decision Date2002-12-12
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Center For Biomaterials and Advanced Technologies. It received FDA 510(k) clearance on 2002-12-12 under 510(k) number K023328. 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 REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH?

REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2002-12-12. The listed applicant is Center For Biomaterials and Advanced Technologies. The 510(k) number is K023328.

When did REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH receive FDA 510(k) clearance?

REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH received FDA 510(k) clearance on 2002-12-12, under 510(k) number K023328.

Who is the listed applicant for REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH?

The FDA 510(k) record lists Center For Biomaterials and Advanced Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH?

The FDA product code for REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH is FTL.

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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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