FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K230966 |
A2 Medical Systems, LLC |
angiOCCLUDE Ligating Clips |
09/19/2023 |
K220006 |
A2 Medical Systems, LLC |
angioLOCK Polymer Ligating Clip |
03/02/2022 |
K051125 |
ABBOTT LABORATORIES |
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 |
06/08/2005 |
K111930 |
ACKERMANN INSTRUMENTE GMBH |
ACKERMANN EUROPCLIP |
11/08/2011 |
K030926 |
ADVANCED SURGICAL PRODUCTS, INC. |
FAST THROW STAINLESS STEEL SURGICAL SUTURE |
07/21/2003 |
K202124 |
Aesculap Inc. |
Aesculap PAS-Port Proximal Anastomosis System |
09/02/2020 |
K080753 |
AESCULAP, INC. |
AESCULAP ENDOSCOPIC CLIP SYTEM |
04/02/2008 |
K081031 |
AESCULAP, INC. |
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE |
05/05/2008 |
K102081 |
AESCULAP, INC. |
ENDOSCOPIC CLIP SYSTEM |
08/06/2010 |
K012342 |
AMERICAN MEDICAL SYSTEMS, INC. |
AMS SOFT-TISSUE APPROXIMATION SYSTEM |
09/05/2001 |
K172479 |
Amsel Medical |
Amsel Occluder Device |
09/14/2017 |
K180650 |
Amsel Medical Corporation |
Amsel Endo Occluder |
11/15/2018 |
K140932 |
AMSEL MEDICAL CORPORATION |
AMSEL OCCLUDER DEVICE |
01/23/2015 |
K032896 |
ANSON MEDICAL LTD. |
ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02 |
03/17/2004 |
K964470 |
APPLIED MEDICAL RESOURCES |
APPLIED MEDICAL CLIP APPLIER |
01/22/1997 |
K993135 |
APPLIED MEDICAL RESOURCES |
IMPLANTABLE CLIP FOR GENERAL SURGERY |
12/01/1999 |
K011236 |
APPLIED MEDICAL RESOURCES CORP. |
MODIFICATION TO IMPLANTABLE CLIP |
05/14/2001 |
K033024 |
APPLIED MEDICAL RESOURCES CORP. |
MODIFICATION TO SUTURE CLINCH |
10/24/2003 |
K032217 |
ARTEMIS MEDICAL, INC. |
14G CORMARK BIOPSY SITE IDENTIFIER |
08/21/2003 |
K003777 |
ARTEMIS MEDICAL, INC. |
CARIS SITE MARKER |
03/06/2001 |
K163261 |
ATRICURE INC. |
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip |
05/19/2017 |
K180010 |
AtriCure, Inc. |
AtriClip FLEX-V |
01/31/2018 |
K131107 |
ATRICURE, INC. |
ATRICLIP GILLINOV-COSGROVE LAA CLIP |
05/14/2013 |
K122276 |
ATRICURE, INC. |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
08/29/2012 |
K142120 |
ATRICURE, INC. |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
08/28/2014 |
K150996 |
ATRICURE, INC. |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
06/17/2015 |
K160454 |
ATRICURE, INC. |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
03/18/2016 |
K172742 |
AtriCure, Inc. |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) |
10/11/2017 |
K093679 |
ATRICURE, INC. |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 |
06/10/2010 |
K153500 |
Atricure, Inc. |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip |
01/27/2016 |
K173031 |
AtriCure, Inc. |
AtriClip LAA Exclusion System with Preloaded PRO╖V Clip |
10/25/2017 |
K033979 |
BY-PASS MAKAFIM LTD. |
CORLINK AUTOMATED ANASTOMOTIC SYSTEM |
03/31/2004 |
K020470 |
BYPASS LTD. |
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE |
03/08/2002 |
K040832 |
CARDICA, INC. |
C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 |
11/10/2005 |
K053524 |
CARDICA, INC. |
C-PORT DISTAL ANASTOMOSIS SYSTEM |
11/16/2006 |
K070548 |
CARDICA, INC. |
C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM |
03/29/2007 |
K073123 |
CARDICA, INC. |
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 |
12/06/2007 |
K073304 |
CARDICA, INC. |
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES |
12/20/2007 |
K063644 |
CARDICA, INC. |
CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM |
01/11/2007 |
K101018 |
CARDICA, INC. |
CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 |
06/25/2010 |
K081225 |
CARDICA, INC. |
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM |
09/05/2008 |
K091017 |
CARDICA, INC. |
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 |
04/29/2009 |
K090872 |
CARDICA, INC. |
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM |
04/21/2009 |
K994160 |
COALESCENT SURGICAL |
COALESCENT SURGICAL SUTURED-CLIP |
02/04/2000 |
K012317 |
COALESCENT SURGICAL |
COALESCENT SURGICAL U-CLIP |
08/31/2001 |
K021407 |
COALESCENT SURGICAL |
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES |
07/03/2002 |
K024366 |
COALESCENT SURGICAL |
COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
01/17/2003 |
K040821 |
COALESCENT SURGICAL |
COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
04/23/2004 |
K003958 |
COALESCENT SURGICAL |
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE |
02/06/2001 |
K031623 |
COALESCENT SURGICAL |
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
07/03/2003 |
K150936 |
CONMED CORPORATION |
SureClip |
10/23/2015 |
K121194 |
COVIDIEN |
ENDO CLIP III 5MM CLIP APPLIER |
05/03/2012 |
K142869 |
COVIDIEN |
Premium Surgiclip III |
10/30/2014 |
K143644 |
COVIDIEN |
Premium Surgiclip┐; Endo Clip┐; AcuClip┐ |
09/14/2015 |
K143598 |
Covidien LLC |
Lapro-Clip Auto Suture Reusable Long Clip Applier |
03/12/2015 |
K192711 |
Dannik |
Dannik Titanium Ligation Clip |
12/20/2019 |
K981239 |
DEROYAL SURGICAL |
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
05/14/1998 |
K040602 |
DESIGN STANDARDS CORP. |
SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
05/10/2004 |
K971588 |
ELECTIVE VASCULAR INTERVENTION INC. (EVI) |
EVI SUTURED-CLIP APPLIER |
10/24/1997 |
K050344 |
ETHICON ENDO SURGERY, INC. |
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER |
03/14/2005 |
K232313 |
Ethicon Endo Surgery, LLC. |
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) |
08/29/2023 |
K110699 |
ETHICON ENDO-SUGERY, LLC |
LIGAMAX 5 |
03/25/2011 |
K150840 |
ETHICON ENDO-SURGERY, LLC |
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier |
09/10/2015 |
K181488 |
Ethicon Endo-Surgery, LLC |
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier |
10/30/2018 |
K100090 |
GENICON |
IMPLANTABLE CLIP |
02/02/2010 |
K030269 |
GENICON, LC |
GENICON CLIP APPLIER |
03/20/2003 |
K033161 |
GYRX, LLC |
VISU-LOCK 5MM CLIP APPLIER |
12/18/2003 |
K981631 |
INFLUENCE, INC. |
INFLUENCE CLIP SYSTEM |
07/28/1998 |
K020879 |
INTEGRATED VASCULAR SYSTEMS, INC. |
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001 |
09/25/2002 |
K953258 |
INTRAMED LABORATORIES, INC. |
TITANIUM HEMOSTATIC CLIP |
01/05/1996 |
K173323 |
LeMaitre Vascular, Inc. |
AnastoClip GC Closure System |
03/08/2018 |
K091987 |
LEMAITRE VASCULAR, INC. |
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP |
04/23/2010 |
K200166 |
M/s. Meril Endo Surgery Private Limited |
Mirus Ligating Clip, Mirus Ligating Clip Applier |
11/23/2020 |
K072525 |
MEDICINELODGE, INC. |
ZIPKNOT, MODEL 1017-3000 |
10/05/2007 |
K962016 |
MEDLINE INDUSTRIES, INC. |
MEDLINE TITANIUM HEMOCLIPS |
07/24/1996 |
K081082 |
MEDTRONIC INC. |
U-CLIP UNI-FIRE, MODEL M65 |
05/07/2008 |
K062821 |
MEDTRONIC NEUROSURGERY |
U-CLIP DEVICE |
12/19/2006 |
K062057 |
MEDTRONIC VASCULAR |
U-CLIP DEVICE, MODEL NC65 |
08/02/2006 |
K053252 |
MEDTRONIC VASCULAR |
U-CLIP DEVICE, MODELS B140, B160 AND B180 |
12/16/2005 |
K013264 |
MICRO STAMPING CORP. |
MICRO STAMPING LIGATING CLIP |
11/29/2001 |
K964109 |
MICROSURGE, INC. |
MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP |
11/27/1996 |
K053255 |
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL |
NEXUS LIGATING CLIP |
03/14/2006 |
K052018 |
MILTEX, INC. |
MILTEX LIGATING CLIP |
11/04/2005 |
K151943 |
NANOVA BIOMATERIALS INC |
Vas-Q-Clip |
03/25/2016 |
K213813 |
NeuraMedica Inc |
DuraFuse Clip and Applier System |
07/22/2022 |
K032238 |
NEUROSEL (MEDICAL) LIMITED |
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER |
09/09/2003 |
K033324 |
NITI MEDICAL TECHNOLOGIES LTD. |
COMPRESSION ANASTOMOSIS CLIP (CAC) |
05/10/2004 |
K041751 |
NITI MEDICAL TECHNOLOGIES LTD. |
COMPRESSION ANASTOMOSIS CLIP (CAC) |
09/16/2004 |
K050356 |
NITI MEDICAL TECHNOLOGIES LTD. |
COMPRESSION ANASTOMOSIS RING (CAR) |
05/05/2005 |
K062008 |
NITI MEDICAL TECHNOLOGIES LTD. |
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) |
08/09/2006 |
K043115 |
NITI MEDICAL TECHNOLOGIES LTD. |
LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) |
12/01/2004 |
K093661 |
NITI SURGICAL SOLUTIONS LTD |
COLONRING |
02/10/2011 |
K020054 |
SANARUS MEDICAL, INC. |
SANARUS INDICA MARKER SYSTEM |
10/16/2002 |
K973652 |
SCION INTERNATIONAL, INC. |
DUOCLIPPER TITANIUM CLIPS |
03/27/1998 |
K011402 |
SENORX, INC. |
BIOPSY SITE MARKER |
07/16/2001 |
K100242 |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER |
02/17/2010 |
K150259 |
TAIWAN SURGICAL CORPORATION |
CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L |
11/06/2015 |
K202994 |
Taiwan Surgical Corporation |
InnoClip Disposable Clip Applier, InnoClip Clip Applier |
01/04/2022 |
K133202 |
TELEFLEX MEDICAL |
HEM-O-LOK LIGATING CLIP |
12/03/2013 |
K062914 |
TELEFLEX MEDICAL |
HEM-O-LOK LIGATION CLIP |
11/02/2006 |
K132658 |
TELEFLEX MEDICAL |
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS |
11/27/2013 |
K161758 |
TELEFLEX MEDICAL |
Weck Auto Endo10 Automatic Endoscopic Clip Applier |
09/07/2016 |
K230480 |
Teleflex Medical |
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) |
04/28/2023 |
K152081 |
Teleflex Medical, Inc. |
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier |
08/26/2015 |
K142777 |
Teleflex Medical, Inc. |
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier |
12/19/2014 |
K061288 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER |
11/02/2006 |
K001450 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER |
07/18/2000 |
K962043 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AUTO SUTURE MODIFIED VCS CLIP APPLIER |
09/23/1996 |
K971201 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AUTO SUTURE* ILM** KIT |
06/03/1997 |
K071406 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER |
11/21/2007 |
K970793 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
IMPLANTABLE CLIP |
07/30/1997 |
K984438 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE |
01/07/1999 |
K991002 |
V. MUELLER NEURO/SPINE |
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP |
06/11/1999 |
K032980 |
VANGUARD MEDICAL CONCEPTS, INC. |
AMI REPROCESSED MULTIPLE CLIP APPLIERS |
12/18/2003 |
K091060 |
VESOCCLUDE MEDICAL, LLC |
VESOCCLUDE LIGATING CLIP |
09/23/2009 |
K152082 |
Vesocclude Medical, LLC |
Vesocclude Polymer Ligating Clip |
02/26/2016 |
K981645 |
VITALITEC INT'L., INC. |
TITANIUM HEMOSTATIC CLIP |
10/13/1998 |
K000278 |
VIVANT MEDICAL, INC. |
VIVANT MEDICAL BIOPSY MARKER SYSTEM |
06/23/2000 |
K030311 |
WECK |
HEM-O-LOK XL CLIP |
02/26/2003 |
K021808 |
WECK |
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER |
08/14/2002 |
K982944 |
WECK CLOSURE SYSTEMS |
HEM-O-LOCK, MODEL 523935 |
11/19/1998 |
K982941 |
WECK CLOSURE SYSTEMS |
HEM-O-LOK MODEL NUMBERS 523900, 523970 |
11/19/1998 |
K993157 |
WECK CLOSURE SYSTEMS |
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 |
12/17/1999 |
K003337 |
WECK CLOSURE SYSTEMS |
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 |
12/21/2000 |
K982313 |
WECK CLOSURE SYSTEMS |
HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS |
08/10/1998 |
K993424 |
Y-CLIP ASSOCIATES |
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP |
12/23/1999 |