Leksell Vantage Stereotactic System— 510(k) K171123
Substantially EquivalentElekta Instrument AB
FDA 510(k) clearance K171123 for Leksell Vantage Stereotactic System, Substantially Equivalent on 2017-09-15. Applicant: Elekta Instrument AB. Device class: 2.
Clearance details
- Applicant
- Elekta Instrument AB
- 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
- Stockholm, SE
Recent devices under product code HAW
view allMore clearances from Elekta Instrument AB
view allAdverse 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 K171123
K-number listed on FDA's recall record- Z-2442-2020 — Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Z-1826-2020 — Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171123.
Data sourced from openFDA. This site is unofficial and independent of the FDA.