510(k) K152558 ยท HAW Neurological Stereotaxic Instrument
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Mar 2, 2016 |
| Received | Sep 9, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152558
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.