Leksell Surgiplan, Model 1006947
FDA 510(k) K080250 · Elekta Instrument AB
510(k) numberK080250
Submission
- Device name
- Leksell Surgiplan, Model 1006947
- Applicant
- Elekta Instrument AB
Stockholm, SE - Received
- January 31, 2008
- Decision date
- May 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
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| 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 |
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| 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 |
Questions and answers
When was Leksell Surgiplan, Model 1006947 cleared by the FDA?
Leksell Surgiplan, Model 1006947 (K080250) received a 510(k) decision of Substantially Equivalent on May 13, 2008, 103 days after the submission was received.
What is the product code of K080250?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.