Leksell Stereotactic System, Injection/ Aspiration Needle Kit
FDA 510(k) clearance K152558 · decided 2016-03-02
Clearance details
- K-number
- K152558
- Device name
- Leksell Stereotactic System, Injection/ Aspiration Needle Kit
- Applicant
- Elekta Instrument AB
- Decision
- Substantially Equivalent
- Date received
- 2015-09-09
- Decision date
- 2016-03-02
- Days to decision
- 175 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Stockholm, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter recall (Z-0227-2025) | Elekta Instrument AB | 2024-11-06 |
| Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Dia recall (Z-1397-2024) | Elekta Instrument AB | 2024-04-16 |
| Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgic recall (Z-1309-2023) | Elekta Instrument AB | 2023-03-30 |