Company ยท SE
Elekta Instrument AB
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2019. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2019 | K190887 | Leksell Vantage Stereotactic System Elekta Instrument AB, SE | HAW |
| Mar 30, 2018 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon Elekta Instrument AB, SE | IWB |
| Feb 9, 2018 | K173791 | Leksell GammaPlan Elekta Instrument AB, SE | IWB |
| Sep 15, 2017 | K171123 | Leksell Vantage Stereotactic System Elekta Instrument AB, SE | HAW |
| Apr 20, 2016 | K160440 | Leksell Gamma Knife Icon Elekta Instrument AB, SE | IWB |
| Mar 2, 2016 | K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit Elekta Instrument AB, SE | HAW |
| Oct 29, 2015 | K151159 | Leksell Gamma Knife Perfexion Elekta Instrument AB, SE | IWB |
| Sep 3, 2015 | K151666 | Leksell GammaPlan Elekta Instrument AB, SE | MUJ |
| Aug 4, 2015 | K151561 | Leksell Gamma Knife Icon Elekta Instrument AB, SE | IWB |
| May 9, 2014 | K133565 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, SE | IWB |
| May 24, 2012 | K120811 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, SE | IWB |
| Dec 21, 2010 | K103093 | LEKSELL GAMMAPLAN Elekta Instrument AB, SE | MUJ |
| Sep 22, 2009 | K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 Elekta Instrument AB, SE | IWB |
| Jul 20, 2009 | K090972 | LEKSELL GAMMAPLAN Elekta Instrument AB, SE | MUJ |
| May 1, 2009 | K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS Elekta Instrument AB, SE | HAW |
| May 13, 2008 | K080250 | LEKSELL SURGIPLAN, MODEL 1006947 Elekta Instrument AB, SE | HAW |
| Mar 5, 2007 | K063512 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, SE | IWB |
| Aug 21, 2006 | K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 Elekta Instrument AB, SE | IWB |
| Jul 5, 2006 | K061540 | LEKSELL GAMMAPLAN Elekta Instrument AB, SE | IWB |
| Jul 25, 2005 | K051746 | ELEKTA ESARTE FRAME SYSTEM Elekta Instrument AB, SE | HAW |
| Jun 1, 2005 | K051022 | GAMMAPLAN Elekta Instrument AB, SE | IWB |
| Sep 8, 2004 | K042269 | LEKSELL GAMMAPLAN 4C WITH MULTIVIEW Elekta Instrument AB, SE | MUJ |
| Jul 23, 2004 | K040979 | ELEKTA MICRODRIVE, MODEL 916716 Elekta Instrument AB, SE | HAW |
| Feb 12, 2004 | K033340 | LEKSELL SURGIPLAN WITH IMAGEMERGE Elekta Instrument AB, SE | HAW |
| Jul 25, 2003 | K031999 | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT Elekta Instrument AB, SE | HAW |
| Jul 25, 2003 | K031980 | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB, SE | HAW |
| Dec 6, 2001 | K013861 | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE Elekta Instrument AB | HAW |
| Sep 24, 1999 | K992882 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT Elekta Instrument AB | HAW |
| Jul 20, 1999 | K991636 | ELEKTA STEREOTACTIC GUIDE Elekta Instrument AB | HAW |
| May 21, 1999 | K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 Elekta Instrument AB | IWB |
| Mar 31, 1998 | K973684 | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND Elekta Instrument AB | HAW |
| Mar 2, 1998 | K972324 | LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB | HAW |
| Apr 24, 1997 | K970291 | ACCESSORIES TO THE STEREOTACTIC BODY FRAM Elekta Instrument AB, SE | IYE |
| Jul 26, 1996 | K961639 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) Elekta Instrument AB, SE | HAW |
| Apr 23, 1996 | K960338 | STEREOTACTIC BODY FRAME Elekta Instrument AB | IYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2024 | Elekta Instrument AB Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933,
Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic Open, Classified |
HAW | K152558 |
| Apr 16, 2024 | Elekta Instrument AB Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereo Open, Classified |
HAW | K152558 |
| Mar 30, 2023 | Elekta Instrument AB Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments:
(1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III;
(2) Part #A2800-15, Backlund Open, Classified |
HAW | K152558 |
| Jun 10, 2020 | Elekta Instrument AB Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 Terminated |
HAW | K171123 |
| Jun 27, 2018 | Elekta Instrument AB Leksell GammaPlan 11.1
Product Usage:
Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Open, Classified |
IWB | K173791 |