Leksell Vantage Stereotactic System— 510(k) K190887
Substantially EquivalentElekta Instrument AB
FDA 510(k) clearance K190887 for Leksell Vantage Stereotactic System, Substantially Equivalent on 2019-08-01. 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 K190887
K-number listed on FDA's recall record- Z-2006-2026 — Brand Name: Leksell Vantage Arc System REF: 1053958
- Z-0433-2026 — Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
- 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 K190887.
Data sourced from openFDA. This site is unofficial and independent of the FDA.