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FDA 510(k)

GOLNIT Non-Absorbable PTFE Surgical Suture

K-Number: K163049 · 2017-06-21

ApplicantAntarma Dba Golnit Sutures
Decision Date2017-06-21
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

NCT07639372A Self-Controlled Clinical Study of Fast-Absorbable Versus Slow-Absorbable Sutures Applied in Ultra Tension-Reducing Suture TechniqueRECRUITING

Related Devices (Code: NBY)

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.

K231277TissueStatDurastat, LLCK192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit SuturesK180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami SurgicalK181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech CorporationK180630PTFE SURGICAL SUTUREOmnia Spa

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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