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FDA 510(k)

SURGIMESH XD

K-Number: K092233 · 2010-06-25

ApplicantAspide Medical
Decision Date2010-06-25
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIMESH XD is the device name listed in this FDA 510(k) record. The listed applicant is Aspide Medical. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K092233. 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 SURGIMESH XD?

SURGIMESH XD is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Aspide Medical. The 510(k) number is K092233.

When did SURGIMESH XD receive FDA 510(k) clearance?

SURGIMESH XD received FDA 510(k) clearance on 2010-06-25, under 510(k) number K092233.

Who is the listed applicant for SURGIMESH XD?

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

What is the FDA product code for SURGIMESH XD?

The FDA product code for SURGIMESH XD 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.

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Other records listing Aspide Medical 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.

K120025SURGIMESH XB - SKIRTEDK072974SURGIMESH XBK061445SURGIMESH WN

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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