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FDA 510(k)

MODIFICATION TO ENDOFAST RELIANT SYSTEM

K-Number: K080836 · 2008-04-21

ApplicantEndogun Medical Systems
Decision Date2008-04-21
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENDOFAST RELIANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endogun Medical Systems. It received FDA 510(k) clearance on 2008-04-21 under 510(k) number K080836. 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 MODIFICATION TO ENDOFAST RELIANT SYSTEM?

MODIFICATION TO ENDOFAST RELIANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Endogun Medical Systems. The 510(k) number is K080836.

When did MODIFICATION TO ENDOFAST RELIANT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ENDOFAST RELIANT SYSTEM received FDA 510(k) clearance on 2008-04-21, under 510(k) number K080836.

Who is the listed applicant for MODIFICATION TO ENDOFAST RELIANT SYSTEM?

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

What is the FDA product code for MODIFICATION TO ENDOFAST RELIANT SYSTEM?

The FDA product code for MODIFICATION TO ENDOFAST RELIANT SYSTEM 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 Endogun Medical Systems 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.

K060329ENDOFAST RELIANT 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

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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