STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM— 510(k) K001284
Substantially EquivalentMedtronic Surgical Navigation Technologies
FDA 510(k) clearance K001284 for STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM, Substantially Equivalent on 2000-06-12. Applicant: Medtronic Surgical Navigation Technologies. Device class: 2.
Clearance details
- Applicant
- Medtronic Surgical Navigation Technologies
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Broomfield, CO, US
Recent devices under product code HAW
view allMore clearances from Medtronic Surgical Navigation Technologies
view all- K050438 — STEALTHSTATION SYSTEM UPDATE
- K043088 — MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
- K030552 — IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
- K030106 — STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
- K022126 — CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K001284
K-number listed on FDA's recall record- Z-2317-2016 — Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- Z-2319-2016 — MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- Z-1578-2014 — BAG 9732315 MOUSE STERILE 15 PK
- Z-1579-2014 — BIOPSY NEEDLE KIT, 9733068, PASSIVE
- Z-1580-2014 — BIT 9733516 2.9mm DRILL STERILE
- Z-1581-2014 — DISP 9730950 STRL SPHERE, 1 PK INSERT
- Z-1582-2014 — DISP 9730951 STRL SPHERE, 5PK INSERT
- Z-1583-2014 — DRAPE 9732722 TUBE STERILE O-ARM 20PK
- Z-1584-2014 — ENT PRGM 9734636 ADD FUSION NAV AxiEM
- Z-1585-2014 — INST 9731132 KIT CR REF FRAME DRIVER 5PK
- Z-1586-2014 — INSTRUMENT TRACKER 9733533XOM ENT 1PK
- Z-1587-2014 — KIT, 9731427, THORACIC TACTILE PROBES
- Z-1588-2014 — MOUSE 9732721 STERILE O-ARM 10PK
- Z-1589-2014 — PACK 9731975 TUMOR RESECTION AXIEM CR
- Z-1590-2014 — PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
- Z-1591-2014 — PATIENT TRACKER 9733534XOM ENT 1PK
- Z-1592-2014 — PIN, 9733235, 100MM, STERILE, PERC REF
- Z-1593-2014 — PIN, 9733236, 150MM, STERILE, PERC REF
- Z-1594-2014 — SHUNT KIT 9733605 NON-INVASIVE
- Z-1595-2014 — SPHERES 8801071 1/TRAY 12PK
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001284.
Data sourced from openFDA. This site is unofficial and independent of the FDA.