Atlas FDA

STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM

FDA 510(k) clearance K001284 · decided 2000-06-12

Clearance details

K-number
K001284
Device name
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
Applicant
Medtronic Surgical Navigation Technologies
Decision
Substantially Equivalent
Date received
2000-04-21
Decision date
2000-06-12
Days to decision
52 days
Clearance type
Traditional
Product code
HAW
Device class
2
Regulation number
882.4560
Medical specialty
Neurology
Advisory committee
Neurology
Location
Broomfield, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BAG 9732315 MOUSE STERILE 15 PK recall (Z-1578-2014)Medtronic Navigation, Inc.2014-05-09
BIOPSY NEEDLE KIT, 9733068, PASSIVE recall (Z-1579-2014)Medtronic Navigation, Inc.2014-05-09
BIT 9733516 2.9mm DRILL STERILE recall (Z-1580-2014)Medtronic Navigation, Inc.2014-05-09
DISP 9730950 STRL SPHERE, 1 PK INSERT recall (Z-1581-2014)Medtronic Navigation, Inc.2014-05-09
DISP 9730951 STRL SPHERE, 5PK INSERT recall (Z-1582-2014)Medtronic Navigation, Inc.2014-05-09
DRAPE 9732722 TUBE STERILE O-ARM 20PK recall (Z-1583-2014)Medtronic Navigation, Inc.2014-05-09
ENT PRGM 9734636 ADD FUSION NAV AxiEM recall (Z-1584-2014)Medtronic Navigation, Inc.2014-05-09
INST 9731132 KIT CR REF FRAME DRIVER 5PK recall (Z-1585-2014)Medtronic Navigation, Inc.2014-05-09
INSTRUMENT TRACKER 9733533XOM ENT 1PK recall (Z-1586-2014)Medtronic Navigation, Inc.2014-05-09
KIT, 9731427, THORACIC TACTILE PROBES recall (Z-1587-2014)Medtronic Navigation, Inc.2014-05-09
MOUSE 9732721 STERILE O-ARM 10PK recall (Z-1588-2014)Medtronic Navigation, Inc.2014-05-09
PACK 9731975 TUMOR RESECTION AXIEM CR recall (Z-1589-2014)Medtronic Navigation, Inc.2014-05-09
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT recall (Z-1590-2014)Medtronic Navigation, Inc.2014-05-09
PATIENT TRACKER 9733534XOM ENT 1PK recall (Z-1591-2014)Medtronic Navigation, Inc.2014-05-09
PIN, 9733235, 100MM, STERILE, PERC REF recall (Z-1592-2014)Medtronic Navigation, Inc.2014-05-09
PIN, 9733236, 150MM, STERILE, PERC REF recall (Z-1593-2014)Medtronic Navigation, Inc.2014-05-09
SHUNT KIT 9733605 NON-INVASIVE recall (Z-1594-2014)Medtronic Navigation, Inc.2014-05-09
SPHERES 8801071 1/TRAY 12PK recall (Z-1595-2014)Medtronic Navigation, Inc.2014-05-09
SPHERES 8801075 5/TRAY 12PK recall (Z-1596-2014)Medtronic Navigation, Inc.2014-05-09
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT recall (Z-1597-2014)Medtronic Navigation, Inc.2014-05-09
TRAJ GUIDE KIT, 9733066, BIOPSY, INT recall (Z-1598-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RES. PACK 9733553 AxiEM S.M. recall (Z-1599-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RESECTION KIT 9733607 NON-INVASIVE recall (Z-1600-2014)Medtronic Navigation, Inc.2014-05-09
TUMOR RESECTION KIT 9733608 SKULL MOUNT recall (Z-1601-2014)Medtronic Navigation, Inc.2014-05-09
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION recall (Z-1602-2014)Medtronic Navigation, Inc.2014-05-09
AxiEM EM Knee Kit, and associated workstation. recall (Z-0718-06)Medtronic Navigation, Inc2006-04-07