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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 a medical device manufactured by Antarma, LLC Dba Golnit Sutures. It received FDA 510(k) clearance on 2019-09-04 under approval 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. It is manufactured by Antarma, LLC Dba Golnit Sutures. The 510(k) number is K192088.

When was GOLNIT Non-aborbable PTFE Surgical Suture approved by the FDA?

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

What company makes GOLNIT Non-aborbable PTFE Surgical Suture?

GOLNIT Non-aborbable PTFE Surgical Suture is manufactured by Antarma, LLC Dba Golnit Sutures.

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.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05261425 Suture Closure Trial COMPLETED NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT07498361 Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial. RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by Antarma, LLC Dba Golnit Sutures

K212888Golnit Nylon Monofilament Suture

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd. K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K163639LS-5 ePTFE SutureLsi Solutions K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

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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