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FDA 510(k)

AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)

K-Number: K132699 · 2013-11-26

ApplicantTyrx, Inc.
Decision Date2013-11-26
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) is the device name listed in this FDA 510(k) record. The listed applicant is Tyrx, Inc.. It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K132699. 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 AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)?

AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Tyrx, Inc.. The 510(k) number is K132699.

When did AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) receive FDA 510(k) clearance?

AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) received FDA 510(k) clearance on 2013-11-26, under 510(k) number K132699.

Who is the listed applicant for AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)?

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

What is the FDA product code for AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)?

The FDA product code for AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) 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 Tyrx, 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.

K131007AIGIS RX N MEDIUM; AIGIS RX N LARGEK130943AIGIS RX R PM/ AIGIS RX R ICDK093524PIVIT A/B ST AND PIVIT A/B ST-R

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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