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FDA 510(k)

SERISCAFFOLD SURGICAL MESH

K-Number: K080442 · 2008-11-13

ApplicantSerica Technologies, Inc.
Decision Date2008-11-13
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERISCAFFOLD SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Serica Technologies, Inc.. It received FDA 510(k) clearance on 2008-11-13 under 510(k) number K080442. 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 SERISCAFFOLD SURGICAL MESH?

SERISCAFFOLD SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is Serica Technologies, Inc.. The 510(k) number is K080442.

When did SERISCAFFOLD SURGICAL MESH receive FDA 510(k) clearance?

SERISCAFFOLD SURGICAL MESH received FDA 510(k) clearance on 2008-11-13, under 510(k) number K080442.

Who is the listed applicant for SERISCAFFOLD SURGICAL MESH?

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

What is the FDA product code for SERISCAFFOLD SURGICAL MESH?

The FDA product code for SERISCAFFOLD 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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