# K152558: Leksell Stereotactic System, Injection/ Aspiration Needle Kit

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Mar 2, 2016 after 175 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K261932: Leksell® Vantage Stereotactic System (2026), 0 descendants of its own

## Recalls of this device
- Sep 25, 2024 · Class I · Z-0227-2025: 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 biops
- Mar 15, 2024 · Class I · Z-1397-2024: 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 stainle
- Mar 1, 2023 · Class II · Z-1309-2023: The incorrect IFU was distributed with the devices.

## Indications for use
Leksell Stereotactic System is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

Source page: https://510kreport.com/device/K152558
Methodology: https://510kreport.com/methodology