STEALTHSTATION TREATMENT GUIDANCE PLATFORM— 510(k) K003201
Substantially EquivalentMedtronic Surgical Navigation Technologies
FDA 510(k) clearance K003201 for STEALTHSTATION TREATMENT GUIDANCE PLATFORM, Substantially Equivalent on 2000-12-12. 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
- Louisville, 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 K003201
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003201.
Data sourced from openFDA. This site is unofficial and independent of the FDA.