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NWJ — Suture, Recombinant Technology Class II

FDA Device Classification

Classification Details

Product Code
NWJ
Device Class
Class II
Regulation Number
878.4494
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K211307tephaGalaSTITCH Absorbable Monofilament SutureMay 27, 2021
K132348tephaTEPHAFLEX BRAIDED SUTURESeptember 5, 2013
K130422tornierPHANTOM FIBER BIOFIBER SUTUREApril 4, 2013
K122487tornierBIOFIBER SYTURESeptember 17, 2012
K100876aesculapAESCULAP MONOMAX ABSORBABLE SUTUREJuly 14, 2010
K082178tephaTEPHAFLEX ABSORBABLE SUTUREOctober 30, 2008
K081099tephaTEPHAFLEX ABSORBABLE SUTUREJuly 15, 2008
K072470entrigue surgicalBIOELAST 5-0 SUTURE, MODEL 500100November 16, 2007
DEN060003tephaTEPHAFLEX ABSORBABLE SUTUREFebruary 8, 2007