FDA 510(k) Applications Submitted by MICHAEL A. DANIEL

FDA 510(k) Number Submission Date Device Name Applicant
K990144 01/19/1999 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM INTUITIVE SURGICAL, INC.
K122042 07/12/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K123676 11/30/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K130124 01/17/2013 CATALYST II AND III CARDIVA MEDICAL, INC.
K120208 01/24/2012 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K040771 03/25/2004 MODIFICATION TO OUTBACK CATHETER LUMEND, INC.
K040821 03/30/2004 COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL
K031005 03/31/2003 LUMEND FRONTRUNNER GW CTO CATHETER LUMEND, INC.
K080987 04/07/2008 BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES BRIDGEPOINT MEDICAL
K111064 04/18/2011 TIGERPAW SYSTEM II LAAX, INC.
K081130 04/21/2008 BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER BRIDGEPOINT MEDICAL
K071168 04/27/2007 THE PORTABLE ANSISCOPE DYANSYS, INC.
K081187 04/28/2008 BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 BRIDGEPOINT MEDICAL
K971588 05/01/1997 EVI SUTURED-CLIP APPLIER ELECTIVE VASCULAR INTERVENTION INC. (EVI)
K021407 05/03/2002 COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES COALESCENT SURGICAL
K041151 05/03/2004 KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES KERBEROS PROXIMAL SOLUTIONS, INC.
K011562 05/21/2001 LUMEND PERCUTANEOUS CATHETER LUMEND, INC.
K031623 05/23/2003 MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL
K141358 05/23/2014 CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES
K071651 06/18/2007 EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC.
K962506 06/27/1996 [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] GYNECARE INNOVATION CENTER
K101961 07/12/2010 TIGERPAW SYSTEM LAAX, INC.
K012317 07/23/2001 COALESCENT SURGICAL U-CLIP COALESCENT SURGICAL
K032298 07/25/2003 MODIFICATION TO OUTBACK CATHETER LUMEND, INC.
K132389 08/01/2013 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED DANIEL & DANIEL CONSULTING
K142113 08/04/2014 ESOPHYX2 HD ENDOGASTRIC SOLUTIONS, INC.
K032411 08/05/2003 JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE JS VASCULAR, INC.
K132475 08/07/2013 FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM FLUOPTICS
K112347 08/15/2011 RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE VASCULAR PATHWAYS, INC.
K023114 09/19/2002 LUMEND FRONTRUNNER CTO CATHETER LUMEND, INC.
K023125 09/19/2002 COALESCENT U-CLIP- AND ACCESSORIES COALESCENT SURGICAL
K963872 09/26/1996 FEMRX MORCELLATOR SYSTEM GYNECARE INNOVATION CENTER
K023223 09/27/2002 MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER LUMEND, INC.
K013284 10/02/2001 LUMEND FRONTRUNNER CTO CORONARY CATHETER LUMEND, INC.
K954648 10/10/1995 FEMRX OPERASTAR SYSTEM GYNECARE INNOVATION CENTER
K954775 10/17/1995 FLO-STAT FLUID MONITORING SYSTEM GYNECARE INNOVATION CENTER
K052930 10/19/2005 NAVIGATOR ENDOSCOPY SYSTEM NEOGUIDE SYSTEMS, INC.
K964441 11/06/1996 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU GYNECARE INNOVATION CENTER
K013664 11/06/2001 COALESCENT SURGICAL U-CLIP COALESCENT SURGICAL
K033535 11/10/2003 LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES LUMEND, INC.
K133466 11/12/2013 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) MAUNA KEA TECHNOLOGIES
K994160 12/09/1999 COALESCENT SURGICAL SUTURED-CLIP COALESCENT SURGICAL
K965001 12/16/1996 INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR INTUITIVE SURGICAL, INC.
K143608 12/19/2014 NovaCross Microcatheter Nitiloop Ltd.
K003958 12/21/2000 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE COALESCENT SURGICAL
K043534 12/22/2004 MODIFICATION TO OUTBACK CATHETER LUMEND, INC.
K024366 12/31/2002 COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL
K152319 08/17/2015 Auris Robotic Endoscopy System (ARES) AURIS SURGICAL ROBOTICS, INC.
K133016 09/25/2013 VENT-OS SINUS DILATION SYSTEM SINUSYS CORPORATION


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