FDA 510(k) Applications for Medical Device Product Code "GAQ"
(Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)

FDA 510(k) Number Applicant Device Name Decision Date
K023411 AESCULAP, INC. STEELEX STERNUM SET 12/19/2002
K991073 CARDIO THORACIC SYSTEMS ACIER SUTURES 07/30/1999
K203855 CoNextions Medical CoNextions TR Tendon Repair System 04/22/2022
K081060 CORE ESSENCE ORTHOPAEDICS, LLC FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 12/24/2008
K030351 CP MEDICAL STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE 03/28/2003
K955723 DAVIS & GECK, INC. STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) 02/27/1996
K141007 DEMETECH CORP. DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE 09/25/2014
K170767 Ethicon, Inc. Surgical Stainless Steel Suture, Stainless Steel Suture 11/01/2017
K193209 Foosin Medical Supplies Inc., Ltd. Wego-Stainless Steel 02/19/2020
K172146 M/s. Meril Endo Surgery Private Limited MERISTEEL 02/01/2018
K984151 MILL POND, INC. STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP 04/28/1999
K022777 ONUX MEDICAL, INC. MANUAL TOUCHE SYSTEM 11/19/2002
K023594 ORTHEON MEDICAL, LLC. TENO FIX 05/15/2003
K140127 PONTIS ORTHOPAEDICS, LLC FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP 05/28/2014
K013059 STONY BROOK SURGICAL INNOVATIONS, INC. STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) 10/22/2001
K082828 SUTURTEK INCORPORATED SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE 10/14/2008
K032468 SUTURTEK INCORPORATED SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE 09/23/2003
K063603 SUTURTEK INCORPORATED SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 02/07/2007
K042606 SYNTHES (USA) MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE 05/27/2005
K041333 SYNTHES (USA) SYNTHES (USA) TITANIUM WIRE 08/27/2004


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