GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Class II

FDA Device Classification

Classification Details

Product Code
GAQ
Device Class
Class II
Regulation Number
878.4495
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203855conextions medicalCoNextions TR Tendon Repair SystemApril 22, 2022
K193209foosin medical supplies incWego-Stainless SteelFebruary 19, 2020
K172146m/s. meril endo surgery private limitedMERISTEELFebruary 1, 2018
K170767ethiconSurgical Stainless Steel Suture, Stainless Steel SutureNovember 1, 2017
K141007demetechDEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURESeptember 25, 2014
K140127pontis orthopaedicsFERROFIBRE STAINLESS STEEL SUTURE WITH CRIMPMay 28, 2014
K081060core essence orthopaedicsFERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5December 24, 2008
K082828suturtek incorporatedSUTURTEK 360 DEGREE STERNAL CLOSURE DEVICEOctober 14, 2008
K063603suturtek incorporatedSUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17February 7, 2007
K042606synthes (usa)MODIFICATION TO:SYNTHES (USA) TITANIUM WIREMay 27, 2005
K041333synthes (usa)SYNTHES (USA) TITANIUM WIREAugust 27, 2004
K032468suturtek incorporatedSUTURTEK FASTCLOSE STERNUM CLOSURE DEVICESeptember 23, 2003
K023594ortheon medicalTENO FIXMay 15, 2003
K030351cp medicalSTAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLEMarch 28, 2003
K023411aesculapSTEELEX STERNUM SETDecember 19, 2002
K022777onux medicalMANUAL TOUCHE SYSTEMNovember 19, 2002
K013059stony brook surgical innovationsSTONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)October 22, 2001
K991073cardio thoracic systemsACIER SUTURESJuly 30, 1999
K984151mill pondSTAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USPApril 28, 1999
K955723davis and geckSTAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)February 27, 1996