FDA 510(k) Applications Submitted by Tammy B Carrea
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090902 |
04/01/2009 |
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 |
TRANSENTERIX, INC. |
| K091697 |
06/10/2009 |
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 |
TRANSENTERIX, INC. |
| K141622 |
06/17/2014 |
ILLUMINATED MEDIASTINOSCOPE |
AEGIS SURGICAL LTD |
| K153162 |
11/02/2015 |
Hypocore |
NOVOCOR MEDICAL SYSTEMS, INC |
| K080004 |
01/02/2008 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES, INC. |
| K120403 |
02/09/2012 |
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER |
TRANSENTERIX, INC. |
| K040687 |
03/16/2004 |
ONEDOSE PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES INC |
| K150722 |
03/20/2015 |
EnFocus 2300, EnFocus 4400 |
BIOPTIGEN, INC. |
| K061051 |
04/17/2006 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER |
SICEL TECHNOLOGIES, INC. |
| K071399 |
05/21/2007 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 |
SICEL TECHNOLOGIES, INC. |
| K122299 |
07/31/2012 |
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR |
TRANSENTERIX, INC. |
| K052118 |
08/04/2005 |
DOSE VERIFICATION SYSTEM |
SICEL TECHNOLOGIES, INC. |
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