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FDA 510(k)

ENDOTINE RIBBON

K-Number: K051415 · 2005-06-23

ApplicantCoapt Systems, Inc.
Decision Date2005-06-23
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOTINE RIBBON is the device name listed in this FDA 510(k) record. The listed applicant is Coapt Systems, Inc.. It received FDA 510(k) clearance on 2005-06-23 under 510(k) number K051415. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOTINE RIBBON?

ENDOTINE RIBBON is a medical device that received FDA 510(k) clearance on 2005-06-23. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K051415.

When did ENDOTINE RIBBON receive FDA 510(k) clearance?

ENDOTINE RIBBON received FDA 510(k) clearance on 2005-06-23, under 510(k) number K051415.

Who is the listed applicant for ENDOTINE RIBBON?

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

What is the FDA product code for ENDOTINE RIBBON?

The FDA product code for ENDOTINE RIBBON is GAM.

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Other records listing Coapt Systems, 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.

K083783VF LIQUIGELK080956MODIFICATION TO VF GEL PLUSK071663VF GEL PLUSK060248ULTRATINE TRANSBLEPHK060249ULTRATINE FOREHEADK060828MODIFICATION TO ENDOTINE RIBBON

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Related Devices (Code: GAM)

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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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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