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FDA 510(k)

MODIFICATION TO ENDOTINE RIBBON

K-Number: K060828 · 2006-04-19

ApplicantCoapt Systems, Inc.
Decision Date2006-04-19
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2006-04-19 under 510(k) number K060828. 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 MODIFICATION TO ENDOTINE RIBBON?

MODIFICATION TO ENDOTINE RIBBON is a medical device that received FDA 510(k) clearance on 2006-04-19. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K060828.

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

MODIFICATION TO ENDOTINE RIBBON received FDA 510(k) clearance on 2006-04-19, under 510(k) number K060828.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO ENDOTINE RIBBON?

The FDA product code for MODIFICATION TO 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 PLUSK060249ULTRATINE FOREHEADK060248ULTRATINE TRANSBLEPHK051415ENDOTINE 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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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