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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