Leksell Vantage Stereotactic System
FDA 510(k) K190887 · Elekta Instrument AB
510(k) numberK190887
Submission
- Device name
- Leksell Vantage Stereotactic System
- Applicant
- Elekta Instrument AB
Stockholm, SE - Received
- April 4, 2019
- Decision date
- August 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB · Traditional | 03/30/2018SE |
| K173791 | Leksell GammaPlanIWB · Traditional | 02/09/2018SE |
| K171123 | Leksell Vantage Stereotactic SystemHAW · Traditional | 09/15/2017SE |
| K160440 | Leksell Gamma Knife IconIWB · Traditional | 04/20/2016SE |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW · Special | 03/02/2016SE |
| K151159 | Leksell Gamma Knife PerfexionIWB · Traditional | 10/29/2015SE |
| K151666 | Leksell GammaPlanMUJ · Traditional | 09/03/2015SE |
| K151561 | Leksell Gamma Knife IconIWB · Traditional | 08/04/2015SE |
| K133565 | Leksell Gamma Knife PerfexionIWB · Traditional | 05/09/2014SE |
| K120811 | Leksell Gamma Knife PerfexionIWB · Traditional | 05/24/2012SE |
Questions and answers
When was Leksell Vantage Stereotactic System cleared by the FDA?
Leksell Vantage Stereotactic System (K190887) received a 510(k) decision of Substantially Equivalent on August 1, 2019, 119 days after the submission was received.
What is the product code of K190887?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.