FDA 510(k)

GOLNIT Non-Absorbable PTFE Surgical Suture

N.º K: K163049 · 2017-06-21

Fecha de decisión2017-06-21

Código de productoNBY

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

GOLNIT Non-Absorbable PTFE Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Antarma Dba Golnit Sutures. It received FDA 510(k) clearance on 2017-06-21 under 510(k) number K163049. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GOLNIT Non-Absorbable PTFE Surgical Suture?

GOLNIT Non-Absorbable PTFE Surgical Suture is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Antarma Dba Golnit Sutures. The 510(k) number is K163049.

When did GOLNIT Non-Absorbable PTFE Surgical Suture receive FDA 510(k) clearance?

GOLNIT Non-Absorbable PTFE Surgical Suture received FDA 510(k) clearance on 2017-06-21, under 510(k) number K163049.

Who is the listed applicant for GOLNIT Non-Absorbable PTFE Surgical Suture?

The FDA 510(k) record lists Antarma Dba Golnit Sutures as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOLNIT Non-Absorbable PTFE Surgical Suture?

The FDA product code for GOLNIT Non-Absorbable PTFE Surgical Suture is NBY.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: NBY)

K231277TissueStatDurastat, LLC K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures K180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami Surgical K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

Fuente oficial

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