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FDA 510(k)

3DMax Light Mesh

K-Number: K241250 · 2024-06-14

ApplicantDavol Inc., Subsidiary of C. R. Bard, Inc.
Decision Date2024-06-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3DMax Light Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K241250. 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 3DMax Light Mesh?

3DMax Light Mesh is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. The 510(k) number is K241250.

When did 3DMax Light Mesh receive FDA 510(k) clearance?

3DMax Light Mesh received FDA 510(k) clearance on 2024-06-14, under 510(k) number K241250.

Who is the listed applicant for 3DMax Light Mesh?

The FDA 510(k) record lists Davol Inc., Subsidiary of C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DMax Light Mesh?

The FDA product code for 3DMax Light Mesh is FTL.

Other records listing Davol Inc., Subsidiary of C. R. Bard, 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.

K251955Onflex™ MeshK233402Bard 3DMax MeshK191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners

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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