FDA 510(k) Applications Submitted by KEVIN J O'CONNELL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200241 |
01/31/2020 |
TempSure System |
Cynosure LLC |
| K150230 |
02/02/2015 |
SculpSure |
CYNOSURE, INC. |
| K150724 |
03/20/2015 |
SculpSure |
CYNOSURE, INC. |
| K140719 |
03/21/2014 |
PICOSURE WORKSTATION |
CYNOSURE, INC. |
| K061893 |
07/03/2006 |
INTEGRA RADIONICS XKNIFE RT 4 |
INTEGRA RADIONICS, INC. |
| K983603 |
10/14/1998 |
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME |
RADIONICS, INC. |
| K133473 |
11/12/2013 |
ILUMINAGE SKIN SMOOTHING LASER |
CYNOSURE, INC. |
| K083414 |
11/18/2008 |
RADIONICS XKNIFE HDRT SYSTEM |
INTEGRA RADIONICS, INC. |
| K990326 |
02/02/1999 |
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII |
RADIONICS SOFTWARE APPLICATIONS, INC. |
| K100417 |
02/16/2010 |
XKNIFE 5 |
INTEGRA RADIONICS, INC. |
| K010548 |
02/26/2001 |
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K030697 |
03/06/2003 |
RADIONICS SINGLE USE GROUND PAD (DGP-HP) |
RADIONICS, INC. |
| K090864 |
03/30/2009 |
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
INTEGRA RADIONICS, INC. |
| K991399 |
04/22/1999 |
RADIONICS MICROELECTRODE KIT |
RADIONICS, INC. |
| K001431 |
05/08/2000 |
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS, INC. |
| K081459 |
05/23/2008 |
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM |
INTEGRA RADIONICS, INC. |
| K021942 |
06/13/2002 |
RADIONICS POLE NEEDLES |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K071669 |
06/19/2007 |
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP |
INTEGRA RADIONICS, INC. |
| K111741 |
06/21/2011 |
INTEGRA(TM) CUSA NXT(TM) BONE TIPS |
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI |
| K001950 |
06/27/2000 |
OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS, INC. |
| K992226 |
07/02/1999 |
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM |
RADIONICS, INC. |
| K032054 |
07/02/2003 |
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K992379 |
07/16/1999 |
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER |
RADIONICS, INC. |
| K051947 |
07/18/2005 |
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K041997 |
07/26/2004 |
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K102258 |
08/10/2010 |
CUSA NXT EXTENDED LENGTH TIP |
INTEGRA RADIONICS, INC. |
| K973017 |
08/13/1997 |
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP |
SYNTHES (USA) |
| K992721 |
08/13/1999 |
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE |
RADIONICS, INC. |
| K012850 |
08/24/2001 |
RECORDING AND STIMULATING ELECTRODE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K072454 |
08/31/2007 |
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS |
INTEGRA RADIONICS, INC. |
| K023519 |
10/21/2002 |
RADIONICS VARILINK 2 |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K063230 |
10/25/2006 |
INTEGRA RADIONICS IMAGEFUSION 3 |
INTEGRA RADIONICS, INC. |
| K013661 |
11/06/2001 |
XPLAN 2.2 WITH THE BODY SYSTEM |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K984245 |
11/27/1998 |
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS |
RADIONICS, INC. |
| K974908 |
12/31/1997 |
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES |
SYNTHES (USA) |
| K000057 |
01/10/2000 |
RADIONICS LUMBOPERITONEAL SHUNT |
RADIONICS, INC. |
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