FDA 510(k) Applications Submitted by AESCULAP, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K002824 |
09/11/2000 |
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM |
AESCULAP, INC. |
K003463 |
11/07/2000 |
SOCON SPINAL SYSTEM |
AESCULAP, INC. |
K003740 |
12/04/2000 |
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION |
AESCULAP, INC. |
K003759 |
12/06/2000 |
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR |
AESCULAP, INC. |
K130596 |
03/07/2013 |
CAIMAN SEAL AND CUT TECHNOLOGY |
AESCULAP, INC. |
K140839 |
04/02/2014 |
CAIMAN SEAL AND CUT TECHNOLOGY |
AESCULAP, INC. |
K151696 |
06/23/2015 |
Caiman Seal and Cut Technology |
AESCULAP, INC. |
K151858 |
07/08/2015 |
Caiman Seal and Cut Technology |
Aesculap, Inc. |
K101937 |
07/12/2010 |
HYBRID TROCAR SYSTEM |
AESCULAP, INC. |
K102081 |
07/26/2010 |
ENDOSCOPIC CLIP SYSTEM |
AESCULAP, INC. |
K122353 |
08/03/2012 |
CRAINFIX 2 TITANIUM CLAMP SYSTEM |
AESCULAP, INC. |
K122791 |
09/12/2012 |
LYOPLANT ONLAY |
AESCULAP, INC. |
K123102 |
10/02/2012 |
SOVEREIGN MINI |
AESCULAP, INC. |
K142970 |
10/14/2014 |
SterilContainer S System |
AESCULAP, INC. |
K143729 |
12/29/2014 |
SterilContainer S |
AESCULAP, INC. |
K151242 |
05/11/2015 |
SterilContainer S |
Aesculap, Inc. |
K030556 |
02/21/2003 |
STEELEX ELECTRODE SET |
AESCULAP, INC. |
K031286 |
04/23/2003 |
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
K032059 |
07/02/2003 |
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM |
AESCULAP, INC. |
K022942 |
09/05/2002 |
CRANIOCUT |
AESCULAP, INC. |
K023411 |
10/11/2002 |
STEELEX STERNUM SET |
AESCULAP, INC. |
K013569 |
10/29/2001 |
ORTHOPILOT 2 |
AESCULAP, INC. |
K014149 |
12/18/2001 |
PAEDISCOPE, MODEL # P010A AND PF011A |
AESCULAP, INC. |
K021327 |
04/26/2002 |
ORTHOPILOT HTO MODULE |
AESCULAP, INC. |
K160393 |
02/11/2016 |
AdTec |
AESCULAP, INC. |
K170683 |
03/07/2017 |
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments |
Aesculap, Inc. |
K172907 |
09/25/2017 |
ELAN 4 Air Motor System |
Aesculap, Inc. |
K183180 |
11/19/2018 |
Caiman 5 Maryland |
Aesculap, Inc. |
K040017 |
01/06/2004 |
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) |
AESCULAP, INC. |
K030367 |
02/04/2003 |
COLUMBUS (PS) |
AESCULAP, INC. |
K020728 |
03/06/2002 |
MIETHKE SHUNT SYSTEM |
AESCULAP, INC. |
K050979 |
04/19/2005 |
S4 SPINAL SYSTEM |
AESCULAP, INC. |
K021313 |
04/25/2002 |
SEARCH EVOLUTION TOTAL KNEE SYSTEM |
AESCULAP, INC. |
K032108 |
07/08/2003 |
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) |
AESCULAP, INC. |
K022672 |
08/12/2002 |
COLUMBUS TOTAL KNEE SYSTEM (CR) |
AESCULAP, INC. |
K042344 |
08/30/2004 |
EXCIA TOTAL HIP SYSTEM |
AESCULAP, INC. |
K023788 |
11/13/2002 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
K011030 |
04/05/2001 |
AESCULAP -MIETHKE SHUNT SYSTEM |
AESCULAP, INC. |
K002871 |
09/14/2000 |
MODIFICATION TO YASARGIL ANEURYSM CLIPS |
AESCULAP, INC. |
K003519 |
11/15/2000 |
YASARGIL PERMANENT ANEURYSM CLIPS |
AESCULAP, INC. |
K003612 |
11/22/2000 |
MICROSPEED EC MOTORSYSTEM GD650/GD653 |
AESCULAP, INC. |
K142315 |
08/19/2014 |
MINOP Disposable Introducer 26F |
AESCULAP, INC. |
K093493 |
11/10/2009 |
AESCULAP STERILCONTAINER S |
AESCULAP, INC. |
K110206 |
01/25/2011 |
AESCULAP- MEITHKE SHUNT SYSTEM |
AESCULAP, INC. |
K140343 |
02/11/2014 |
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP |
AESCULAP, INC. |
K060437 |
02/21/2006 |
EXCIA TOTAL HIP SYSTEM WITH U-CAP |
AESCULAP, INC. |
K120559 |
02/24/2012 |
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
K050804 |
03/30/2005 |
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM |
AESCULAP, INC. |
K100876 |
03/30/2010 |
AESCULAP MONOMAX ABSORBABLE SUTURE |
AESCULAP, INC. |
K050813 |
03/31/2005 |
ABC 2 SCREW |
AESCULAP, INC. |
K060918 |
04/04/2006 |
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD |
AESCULAP, INC. |
K061344 |
05/15/2006 |
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET |
AESCULAP, INC. |
K131500 |
05/24/2013 |
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS |
AESCULAP, INC. |
K141687 |
06/12/2014 |
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
K121976 |
07/05/2012 |
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE |
AESCULAP, INC. |
K111959 |
07/11/2011 |
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE |
AESCULAP, INC. |
K062413 |
08/17/2006 |
AESCULAP PNEUMATIC KERRISON |
AESCULAP, INC. |
K192266 |
08/21/2019 |
M. Blue Adjustable Shunt System |
Aesculap, Inc. |
K122734 |
09/06/2012 |
AESCULAP NOVOSYN ABSORBABLE SUTURE |
AESCULAP, INC. |
K062684 |
09/08/2006 |
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD |
AESCULAP, INC. |
K103003 |
10/12/2010 |
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM |
AESCULAP, INC. |
K073168 |
11/09/2007 |
AESCULAP PRIMELINE CONTAINER LTD. |
AESCULAP, INC. |
K053390 |
12/05/2005 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
K053526 |
12/19/2005 |
MICROSPEED UNI MOTOR SYSTEM |
AESCULAP, INC. |
K133890 |
12/20/2013 |
AESCULAP OPTILENE NONABSORBABLE SUTURE |
AESCULAP, INC. |
K190174 |
02/01/2019 |
Miethke Shunt System GAV 2.0 and SA 2.0 Valves |
Aesculap, Inc. |
K180321 |
02/05/2018 |
Aesculap Optilene Nonabsorbable Suture |
Aesculap, Inc. |
K170661 |
03/03/2017 |
Novosyn Quick Absorbable Suture |
Aesculap, Inc. |
K171001 |
04/04/2017 |
Monosyn Quick Synthetic Absorbable Surgical Suture |
Aesculap, Inc. |
K200950 |
04/09/2020 |
Ventricular Catheter |
Aesculap, Inc. |
K151165 |
05/01/2015 |
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture |
AESCULAP, INC. |
K151865 |
07/08/2015 |
PremiPatch PTFE Pledget |
AESCULAP, INC. |
K202391 |
08/21/2020 |
DIR 800 |
Aesculap, Inc. |
K172709 |
09/08/2017 |
ELAN 4 Electro Motor System Tools |
Aesculap, Inc. |
K182527 |
09/14/2018 |
ELAN 4 Tools |
Aesculap, Inc. |
K183203 |
11/19/2018 |
ELAN 4 Tools |
Aesculap, Inc. |
K010752 |
03/13/2001 |
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY |
AESCULAP, INC. |
K980121 |
01/14/1998 |
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS |
AESCULAP, INC. |
K980484 |
02/09/1998 |
AESCULAP SPINE SYSTEM EVOLUTION |
AESCULAP, INC. |
K974706 |
12/16/1997 |
AESCULAP ABC CERVICAL PLATING SYSTEM |
AESCULAP, INC. |
K000486 |
02/14/2000 |
ABC CERVICAL PLATING SYSTEM |
AESCULAP, INC. |
K001080 |
04/04/2000 |
SPINE SYSTEM EVOLUTION |
AESCULAP, INC. |
K001330 |
04/27/2000 |
SOVEREIGN BIPOLAR INSTRUMENTS |
AESCULAP, INC. |
K982623 |
07/28/1998 |
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM |
AESCULAP, INC. |
K982914 |
08/19/1998 |
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS |
AESCULAP, INC. |
K993551 |
10/19/1999 |
SOCON SPINAL SYSTEM |
AESCULAP, INC. |
K984109 |
11/17/1998 |
AESCULAP AXIAL CLIP APPLIER |
AESCULAP, INC. |
K060152 |
01/20/2006 |
MODIFICATION TO S4 SPINAL SYSTEM |
AESCULAP, INC. |
K081031 |
04/11/2008 |
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE |
AESCULAP, INC. |
K061424 |
05/23/2006 |
CELSITE/ CELSITE CONCEPT, ACCESS PORTS |
AESCULAP, INC. |
K172850 |
09/20/2017 |
SterilContainer with PrimeLine Pro Lid |
Aesculap, Inc. |
K014172 |
12/20/2001 |
NELSON ELECTROSURGICAL UNIT, MODEL GN640 |
AESCULAP, INC. |
K014207 |
12/21/2001 |
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 |
AESCULAP, INC. |
K110695 |
03/14/2011 |
BIPOLAR HF DEVICE |
AESCULAP, INC. |
K080753 |
03/17/2008 |
AESCULAP ENDOSCOPIC CLIP SYTEM |
AESCULAP, INC. |
K091692 |
06/10/2009 |
AESCULAP PEEK CRANIOFIX |
AESCULAP, INC. |
K061704 |
06/16/2006 |
OPTILENE MESH |
AESCULAP, INC. |
K061699 |
06/16/2006 |
EXCIA |
AESCULAP, INC. |
K062012 |
07/17/2006 |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
AESCULAP, INC. |
K062327 |
08/10/2006 |
MODIFICATION TO S4 SPINAL SYSTEM |
AESCULAP, INC. |
K062406 |
08/17/2006 |
AESCULAP NEURO PATTIES |
AESCULAP, INC. |
K011102 |
04/11/2001 |
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM |
AESCULAP, INC. |
K011556 |
05/21/2001 |
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM |
AESCULAP, INC. |
K012219 |
07/16/2001 |
SCALPFIX CLIP SYSTEM |
AESCULAP, INC. |
K012986 |
09/06/2001 |
BIPOLAR IRRIGATION FORCEPS |
AESCULAP, INC. |
K003608 |
11/22/2000 |
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY |
AESCULAP, INC. |
K003965 |
12/22/2000 |
MRI SAFE INSTRUMENTS |
AESCULAP, INC. |
K984124 |
11/18/1998 |
AESCULAP XENON LIGHT SOURCE |
AESCULAP, INC. |
K960473 |
02/01/1996 |
AESCULAP POWER SYSTEM HANDPIECE |
AESCULAP, INC. |
K983365 |
09/24/1998 |
AESCULAP MINOP SYSTEM |
AESCULAP, INC. |
K973736 |
10/01/1997 |
AESCULAP HILAN MOTOR SYSTEM |
AESCULAP, INC. |
K970541 |
02/12/1997 |
AESCULAP MODULAR MONOPOLAR ELECTRODES |
AESCULAP, INC. |
K980686 |
02/23/1998 |
AESCULAP HILAN MOTOR SYSTEM |
AESCULAP, INC. |
K971310 |
04/08/1997 |
AESCULAP JET IRRIGATION SYSTEM |
AESCULAP, INC. |
K992053 |
06/18/1999 |
AESCULAP VASCULAR INSTRUMENTS |
AESCULAP, INC. |
K972332 |
06/23/1997 |
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM |
AESCULAP, INC. |
K962493 |
06/26/1996 |
ENDOSCOPIC CLIP APPLIER |
AESCULAP, INC. |
K953968 |
08/22/1995 |
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) |
AESCULAP, INC. |
K954652 |
10/10/1995 |
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS |
AESCULAP, INC. |
K964281 |
10/28/1996 |
AESCULAP ANGLED NEUROENDOSCOPES |
AESCULAP, INC. |
K040080 |
01/15/2004 |
AESCULAP ABSORBABLE CRANIOFIX |
AESCULAP, INC. |
K060492 |
02/24/2006 |
AESCULAP CRANIOFACIAL PLATE AND SCREW |
AESCULAP, INC. |
K060528 |
02/28/2006 |
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE |
AESCULAP, INC. |
K030698 |
03/06/2003 |
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV |
AESCULAP, INC. |
K060707 |
03/16/2006 |
AESCULAP BIPOLAR ACETABULAR CUP |
AESCULAP, INC. |
K060762 |
03/21/2006 |
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM |
AESCULAP, INC. |
K050752 |
03/23/2005 |
AESCULAP ORTHOPILOT 2 THA V 2.0 |
AESCULAP, INC. |
K031303 |
04/24/2003 |
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) |
AESCULAP, INC. |
K041623 |
06/16/2004 |
REUSABLE STERILCONTAINER FILTER MODEL #JK090 |
AESCULAP, INC. |
K062009 |
07/17/2006 |
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T |
AESCULAP, INC. |
K032198 |
07/18/2003 |
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP |
AESCULAP, INC. |
K063017 |
10/02/2006 |
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM |
AESCULAP, INC. |
K043041 |
11/04/2004 |
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) |
AESCULAP, INC. |
K053158 |
11/14/2005 |
OPTILENE MESH LP |
AESCULAP, INC. |
K053389 |
12/05/2005 |
AESCULAP STERILCONTAINER SYSTEM |
AESCULAP, INC. |
K053579 |
12/22/2005 |
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE |
AESCULAP, INC. |
K024349 |
12/30/2002 |
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER |
AESCULAP, INC. |
K180914 |
04/09/2018 |
Aesculap Slim Clip Applier |
Aesculap, Inc. |
K182032 |
07/30/2018 |
SterilContainer S System |
Aesculap, Inc. |
K173271 |
10/12/2017 |
Aesculap Slim Clip Applier Forceps |
Aesculap, Inc. |
K152960 |
10/07/2015 |
ELAN 4 Motor System |
AESCULAP, INC. |
K192056 |
08/01/2019 |
JJ Series Container System |
Aesculap, Inc. |
K182414 |
09/04/2018 |
Aesculap« SterilContainer(TM) S2 System |
Aesculap, Inc. |
K193582 |
12/23/2019 |
SterilContainer S2 System |
Aesculap, Inc. |
K000021 |
01/04/2000 |
AESCULAP BONE WAX |
AESCULAP, INC. |
K990088 |
01/11/1999 |
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE |
AESCULAP, INC. |
K990089 |
01/11/1999 |
SILKAM NONABSORBABLE SILK SURGICAL SUTURE |
AESCULAP, INC. |
K990090 |
01/11/1999 |
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE |
AESCULAP, INC. |
K980703 |
02/23/1998 |
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
AESCULAP, INC. |
K980704 |
02/23/1998 |
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
K991223 |
04/12/1999 |
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC |
AESCULAP, INC. |
K011372 |
05/04/2001 |
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
K011375 |
05/04/2001 |
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
K012201 |
07/13/2001 |
PREMICRON NONABSORBABLE PET SURGICAL SUTURE |
AESCULAP, INC. |
K970285 |
01/24/1997 |
AESUCLAP SOCON SPINAL SYSTEM |
AESCULAP, INC. |
K960470 |
02/01/1996 |
NEURO-PATCH |
AESCULAP, INC. |
K970549 |
02/12/1997 |
TITANIUM ALLOY BONE SCREWS |
AESCULAP, INC. |
K970851 |
03/07/1997 |
LYOPLANT DURA SUBSTITUTE(VARIOUS) |
AESCULAP, INC. |
K954394 |
09/18/1995 |
AESCULAP VENTRICULOSCOPE SYSTEM |
AESCULAP, INC. |
K983758 |
10/26/1998 |
YASARGIL TITANIUM ANEURYSM CLIPS |
AESCULAP, INC. |
K970050 |
01/06/1997 |
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) |
AESCULAP, INC. |
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