Elekta Instrument AB
Lake Forest, CA, US
Elekta Instrument AB appears in FDA device records in Lake Forest, CA. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 35 510(k) clearances for Elekta Instrument AB between 1996 and 2019. The busiest year on record is 1999, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 3 |
| 2001 | 1 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190887 | Leksell Vantage Stereotactic System | HAW | Substantially Equivalent | |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | IWB | Substantially Equivalent | |
| K173791 | Leksell GammaPlan | IWB | Substantially Equivalent | |
| K171123 | Leksell Vantage Stereotactic System | HAW | Substantially Equivalent | |
| K160440 | Leksell Gamma Knife Icon | IWB | Substantially Equivalent | |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | HAW | Substantially Equivalent | |
| K151159 | Leksell Gamma Knife Perfexion | IWB | Substantially Equivalent | |
| K151666 | Leksell GammaPlan | MUJ | Substantially Equivalent | |
| K151561 | Leksell Gamma Knife Icon | IWB | Substantially Equivalent | |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | IWB | Substantially Equivalent | |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | IWB | Substantially Equivalent | |
| K103093 | LEKSELL GAMMAPLAN | MUJ | Substantially Equivalent | |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | IWB | Substantially Equivalent | |
| K090972 | LEKSELL GAMMAPLAN | MUJ | Substantially Equivalent | |
| K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | HAW | Substantially Equivalent | |
| K080250 | LEKSELL SURGIPLAN, MODEL 1006947 | HAW | Substantially Equivalent | |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | IWB | Substantially Equivalent | |
| K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | IWB | Substantially Equivalent | |
| K061540 | LEKSELL GAMMAPLAN | IWB | Substantially Equivalent | |
| K051746 | ELEKTA ESARTE FRAME SYSTEM | HAW | Substantially Equivalent | |
| K051022 | GAMMAPLAN | IWB | Substantially Equivalent | |
| K042269 | LEKSELL GAMMAPLAN 4C WITH MULTIVIEW | MUJ | Substantially Equivalent | |
| K040979 | ELEKTA MICRODRIVE, MODEL 916716 | HAW | Substantially Equivalent | |
| K033340 | LEKSELL SURGIPLAN WITH IMAGEMERGE | HAW | Substantially Equivalent | |
| K031999 | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT | HAW | Substantially Equivalent | |
| K031980 | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | |
| K013861 | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE | HAW | Substantially Equivalent | |
| K992882 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT | HAW | Substantially Equivalent | |
| K991636 | ELEKTA STEREOTACTIC GUIDE | HAW | Substantially Equivalent | |
| K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 | IWB | Substantially Equivalent | |
| K973684 | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND | HAW | Substantially Equivalent | |
| K972324 | LEKSELL STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | |
| K970291 | ACCESSORIES TO THE STEREOTACTIC BODY FRAM | IYE | Substantially Equivalent | |
| K961639 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) | HAW | Substantially Equivalent | |
| K960338 | STEREOTACTIC BODY FRAME | IYE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0227-2025 | 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 System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy. | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. | Class I | Open, Classified | |
| Z-1397-2024 | 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 Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site. | Class I | Open, Classified | |
| Z-1309-2023 | 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 Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front. | The incorrect IFU was distributed with the devices. | Class II | Open, Classified | |
| Z-2442-2020 | Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 | The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. | Class II | Terminated | |
| Z-1412-2019 | Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. | The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain