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FDA 510(k)

GOLNIT Non-aborbable PTFE Surgical Suture

K-Number: K192088 · 2019-09-04

ApplicantAntarma, LLC Dba Golnit Sutures
Decision Date2019-09-04
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOLNIT Non-aborbable PTFE Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Antarma, LLC Dba Golnit Sutures. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K192088. 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-aborbable PTFE Surgical Suture?

GOLNIT Non-aborbable PTFE Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Antarma, LLC Dba Golnit Sutures. The 510(k) number is K192088.

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

GOLNIT Non-aborbable PTFE Surgical Suture received FDA 510(k) clearance on 2019-09-04, under 510(k) number K192088.

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

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

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

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

Other records listing Antarma, LLC Dba Golnit Sutures 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.

K212888Golnit Nylon Monofilament Suture

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, LLCK180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami SurgicalK181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech CorporationK180630PTFE SURGICAL SUTUREOmnia SpaK173922C-PTFETM Surgical SutureCp Medical, Inc.

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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