FDA 510(k) Applications Submitted by IMAGE-GUIDED NEUROLOGICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000195 |
01/21/2000 |
CRANIAL DRILL |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K040334 |
02/11/2004 |
NAVIGUS PASSIVE PROBE, MODEL NP-1000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K050772 |
03/25/2005 |
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K040834 |
03/31/2004 |
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K001096 |
04/04/2000 |
BURR HOLE COVER, MODEL XX |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K001097 |
04/04/2000 |
ACTIVE ARRAY CATHETER, MODEL CS-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K001192 |
04/12/2000 |
SELF ADHERING NAVIGUS GUIDE |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K031885 |
06/18/2003 |
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K011971 |
06/25/2001 |
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K022100 |
06/28/2002 |
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K012366 |
07/26/2001 |
NAVIGUS II TRAJECTORY GUIDE |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K002330 |
08/01/2000 |
NAVIGUS PEEL AWAY INTRODUCER |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K012719 |
08/14/2001 |
NAVIGUS II MR |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K993682 |
11/01/1999 |
MRI EQUIPMENT COVER |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K043091 |
11/09/2004 |
NAVIGUS NEXDRIVE, MODEL MI-3000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K033619 |
11/18/2003 |
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K023949 |
11/27/2002 |
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K024201 |
12/20/2002 |
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K992796 |
08/19/1999 |
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K990907 |
03/18/1999 |
REMOTE INTRODUCER, MODEL PI-1000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K992304 |
07/08/1999 |
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX |
IMAGE-GUIDED NEUROLOGICS, INC. |
| K983539 |
10/09/1998 |
TRAJECTORY GUIDE, MODEL # TGX-XXX |
IMAGE-GUIDED NEUROLOGICS, INC. |
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