FDA 510(k) Applications Submitted by AMY BOUCLY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000060 |
01/10/2000 |
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 |
SENORX, INC. |
| K050090 |
01/14/2005 |
GEL MARK V |
SENORX, INC. |
| K090288 |
02/05/2009 |
ORTHADAPT PR |
PEGASUS BIOLOGICS, INC. |
| K030473 |
02/12/2003 |
SENORX ES-300 |
SENORX, INC. |
| K110538 |
02/25/2011 |
PRO FIXATION SYSTEM |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
| K040706 |
03/18/2004 |
GEL MARK IV |
SENORX, INC. |
| K040842 |
04/01/2004 |
SENORX BIOPSY DEVICE II |
SENORX, INC. |
| K051158 |
05/05/2005 |
ENCOR 7 GAUGE |
SENORX, INC. |
| K011402 |
05/07/2001 |
BIOPSY SITE MARKER |
SENORX, INC. |
| K021707 |
05/23/2002 |
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS |
SENORX, INC. |
| K031938 |
06/23/2003 |
GEL MARK III BIOPSY SITE MARKER |
SENORX, INC. |
| K012004 |
06/27/2001 |
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE |
SENORX, INC. |
| K012023 |
06/28/2001 |
ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE |
SENORX, INC. |
| K042098 |
08/04/2004 |
SENORX INTRODUCER |
SENORX, INC. |
| K112399 |
08/19/2011 |
UNITE BIOMATRIX |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
| K012799 |
08/21/2001 |
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL |
SENORX, INC. |
| K112786 |
09/26/2011 |
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF |
SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. |
| K052857 |
10/11/2005 |
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 |
SENORX, INC. |
| K013641 |
11/05/2001 |
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS |
SENORX, INC. |
| K113460 |
11/22/2011 |
SYNERGY TISSUE MATRIX |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
| K023923 |
11/25/2002 |
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE |
SENORX, INC. |
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