Elekta Instrument AB
Elekta Instrument AB holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2019, with 5 FDA device recalls on record.
Top product codes for Elekta Instrument AB
FDA recalls by Elekta Instrument AB
- 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.
- 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.
- 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.
- Z-2442-2020 — Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Z-1412-2019 — Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Elekta Instrument AB
- K190887 — Leksell Vantage Stereotactic System
- K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
- K173791 — Leksell GammaPlan
- K171123 — Leksell Vantage Stereotactic System
- K160440 — Leksell Gamma Knife Icon
- K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle Kit
- K151159 — Leksell Gamma Knife Perfexion
- K151666 — Leksell GammaPlan
- K151561 — Leksell Gamma Knife Icon
- K133565 — LEKSELL GAMMA KNIFE PERFEXION
- K120811 — LEKSELL GAMMA KNIFE PERFEXION
- K103093 — LEKSELL GAMMAPLAN
- K092083 — EXTEND FRAME SYSTEM, MODEL 1009633
- K090972 — LEKSELL GAMMAPLAN
- K080355 — LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
- K080250 — LEKSELL SURGIPLAN, MODEL 1006947
- K063512 — LEKSELL GAMMA KNIFE PERFEXION
- K061941 — LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
- K061540 — LEKSELL GAMMAPLAN
- K051746 — ELEKTA ESARTE FRAME SYSTEM
- K051022 — GAMMAPLAN
- K042269 — LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
- K040979 — ELEKTA MICRODRIVE, MODEL 916716
- K033340 — LEKSELL SURGIPLAN WITH IMAGEMERGE
- K031980 — MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
- K031999 — ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
- K013861 — MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
- K992882 — LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
- K991636 — ELEKTA STEREOTACTIC GUIDE
- K984328 — LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
- K973684 — LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
- K972324 — LEKSELL STEREOTACTIC SYSTEM
- K970291 — ACCESSORIES TO THE STEREOTACTIC BODY FRAM
- K961639 — LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
- K960338 — STEREOTACTIC BODY FRAME
Data sourced from openFDA. This site is unofficial and independent of the FDA.