FDA 510(k) Applications Submitted by KATHY RACOSKY

FDA 510(k) Number Submission Date Device Name Applicant
K242003 07/09/2024 XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set Aesculap Inc.
K142315 08/19/2014 MINOP Disposable Introducer 26F AESCULAP, INC.
K093493 11/10/2009 AESCULAP STERILCONTAINER S AESCULAP, INC.
K093649 11/25/2009 AESCULAP STERILCONTAINER S AESCULAP
K203739 12/22/2020 ELAN 4 Electro Motor System Aesculap Inc.
K110206 01/25/2011 AESCULAP- MEITHKE SHUNT SYSTEM AESCULAP, INC.
K090299 02/06/2009 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS AESCULAP IMPLANT SYSTEMS
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.
K080584 03/03/2008 METHA SHORT STEM HIP SYSTEM AESCULAP IMPLANT SYSTEM, INC.
K050804 03/30/2005 MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM AESCULAP, INC.
K100876 03/30/2010 AESCULAP MONOMAX ABSORBABLE SUTURE AESCULAP, INC.
K120955 03/30/2012 COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K050813 03/31/2005 ABC 2 SCREW AESCULAP, INC.
K040864 04/02/2004 CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM AESCULAP
K060918 04/04/2006 EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD AESCULAP, INC.
K101281 05/06/2010 VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEM, 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.
K071499 05/31/2007 COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY AESCULAP IMPLANT SYSTEMS, INC.
K141687 06/12/2014 AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM AESCULAP, INC.
K101815 06/30/2010 ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS
K121976 07/05/2012 AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE AESCULAP, INC.
K071916 07/11/2007 METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC.
K111959 07/11/2011 AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE AESCULAP, INC.
K071945 07/13/2007 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS
K092143 07/15/2009 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM AESCULAP IMPLANT SYSTEMS, INC.
K062085 07/21/2006 S4 SPINAL SYSTEM AESCULAP
K102057 07/22/2010 TARGON FN SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K082146 07/30/2008 METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC.
K062413 08/17/2006 AESCULAP PNEUMATIC KERRISON AESCULAP, INC.
K192266 08/21/2019 M. Blue Adjustable Shunt System Aesculap, Inc.
K102424 08/25/2010 PREVISION HIP SYSTEM WITH RECON RING AESCULAP IMPLANT SYSTEMS, LLC
K102505 09/01/2010 HTO PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K122734 09/06/2012 AESCULAP NOVOSYN ABSORBABLE SUTURE AESCULAP, INC.
K062684 09/08/2006 EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD AESCULAP, INC.
K112682 09/15/2011 METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K082991 10/07/2008 BIOLOX DELTA CERAMIC FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC.
K103003 10/12/2010 AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM AESCULAP, INC.
K043079 11/08/2004 BICONTACT HIP SYSTEM WITH U-CAP AESCULAP
K073168 11/09/2007 AESCULAP PRIMELINE CONTAINER LTD. AESCULAP, INC.
K083495 11/25/2008 MODIFICATION TO: METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, 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.
K161853 07/06/2016 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System 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.


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