FDA 510(k) Applications for Medical Device Product Code: NWJ (Suture, Recombinant Technology)

FDA 510(k) Applications for Medical Device Product Code "NWJ"
(Suture, Recombinant Technology)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K100876	AESCULAP, INC.	AESCULAP MONOMAX ABSORBABLE SUTURE	07/14/2010
K072470	ENTRIGUE SURGICAL, INC.	BIOELAST 5-0 SUTURE, MODEL 500100	11/16/2007
K211307	Tepha, Inc.	GalaSTITCH Absorbable Monofilament Suture	05/27/2021
DEN060003	TEPHA, INC.	TEPHAFLEX ABSORBABLE SUTURE	02/08/2007
K082178	TEPHA, INC.	TEPHAFLEX ABSORBABLE SUTURE	10/30/2008
K081099	TEPHA, INC.	TEPHAFLEX ABSORBABLE SUTURE	07/15/2008
K132348	TEPHA, INC.	TEPHAFLEX BRAIDED SUTURE	09/05/2013
K122487	TORNIER, INC.	BIOFIBER SYTURE	09/17/2012
K130422	TORNIER, INC.	PHANTOM FIBER BIOFIBER SUTURE	04/04/2013