FDA 510(k)

ARISTE AB Mesh

K-Number: K211132 · 2022-03-18

Decision Date2022-03-18

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ARISTE AB Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Ariste Medical, LLC. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K211132. 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 ARISTE AB Mesh?

ARISTE AB Mesh is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Ariste Medical, LLC. The 510(k) number is K211132.

When did ARISTE AB Mesh receive FDA 510(k) clearance?

ARISTE AB Mesh received FDA 510(k) clearance on 2022-03-18, under 510(k) number K211132.

Who is the listed applicant for ARISTE AB Mesh?

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

What is the FDA product code for ARISTE AB Mesh?

The FDA product code for ARISTE AB Mesh is FTL.

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 Production K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard 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.