FDA 510(k) Applications for Medical Device Product Code: NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)

FDA 510(k) Applications for Medical Device Product Code "NBY"
(Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K163049	Antarma dba Golnit Sutures	GOLNIT Non-Absorbable PTFE Surgical Suture	06/21/2017
K192088	Antarma LLC dba Golnit Sutures	GOLNIT Non-aborbable PTFE Surgical Suture	09/04/2019
K173922	CP Medical Inc.	C-PTFETM Surgical Suture	03/26/2018
K181578	Demetech Corporation	DemeTECH PTFE Nonabsorbable Surgical Suture	10/11/2018
K173335	Dura Tap LLC	Gazelle PTFE and Suture Delivery Device	02/08/2018
K170842	Foosin Medical Supplies Inc., Ltd.	WEGO-PTFE	07/31/2017
K163639	LSI SOLUTIONS	LS-5 ePTFE Suture	06/02/2017
K180630	OMNIA SPA	PTFE SURGICAL SUTURE	04/06/2018
K132464	OMNIA SPA	PTFE SURGICAL SUTURE	02/12/2014
K191317	Origami Surgical	StitchKit	07/12/2019
K123811	ORIGAMI SURGICAL LLC	STITCHKIT	09/05/2013
K072076	OSTEOGENICS BIOMEDICAL, INC.	CYTOPLAST PTFE SUTURE	10/31/2007
K003028	OSTEOGENICS BIOMEDICAL, INC.	CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC	11/24/2000
K180992	Purgo Biologics Inc.	Biotex	07/16/2019
K140415	RIVERPOINT MEDICAL	MONOTEX	03/26/2014
K160744	Surgical Specialties Corporation	LOOK PTFE Suture	07/13/2016