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FDA 510(k)

REFINE SUPPORT SYSTEM, MODEL 100.0100

K-Number: K092538 · 2010-03-05

ApplicantAlure Medical, Inc.
Decision Date2010-03-05
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REFINE SUPPORT SYSTEM, MODEL 100.0100 is the device name listed in this FDA 510(k) record. The listed applicant is Alure Medical, Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K092538. 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 REFINE SUPPORT SYSTEM, MODEL 100.0100?

REFINE SUPPORT SYSTEM, MODEL 100.0100 is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Alure Medical, Inc.. The 510(k) number is K092538.

When did REFINE SUPPORT SYSTEM, MODEL 100.0100 receive FDA 510(k) clearance?

REFINE SUPPORT SYSTEM, MODEL 100.0100 received FDA 510(k) clearance on 2010-03-05, under 510(k) number K092538.

Who is the listed applicant for REFINE SUPPORT SYSTEM, MODEL 100.0100?

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

What is the FDA product code for REFINE SUPPORT SYSTEM, MODEL 100.0100?

The FDA product code for REFINE SUPPORT SYSTEM, MODEL 100.0100 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 Alure Medical, 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.

K083102REFINE LIFT SYSTEM

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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