FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K Number: K973684
·
Decision Mar 31, 1998
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
35
Review Days
186
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
- K Number
- K973684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Instrument AB
- Date Received
- September 26, 1997
- Decision Date
- March 31, 1998
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.
Zeta Navigation System
FDA 510(k)
FDA Class 2
·Neurology
Stealth AXiS Cranial clinical application
FDA 510(k)
FDA Class 2
·Neurology
NeuroAlign software
FDA 510(k)
FDA Class 2
·Neurology
SOLOPASS 2.0 System
FDA 510(k)
FDA Class 2
·Neurology
Ball Joint Guide Array (66295)
FDA 510(k)
FDA Class 2
·Neurology
EZ-FIDUCIALS
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Elekta Instrument AB
| K Number | Device Name | ||
|---|---|---|---|
| K190887 | Leksell Vantage Stereotactic System | Aug 1, 2019 | Substantially Equivalent |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Mar 30, 2018 | Substantially Equivalent |
| K173791 | Leksell GammaPlan | Feb 9, 2018 | Substantially Equivalent |
| K171123 | Leksell Vantage Stereotactic System | Sep 15, 2017 | Substantially Equivalent |
| K160440 | Leksell Gamma Knife Icon | Apr 20, 2016 | Substantially Equivalent |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | Mar 2, 2016 | Substantially Equivalent |
| K151159 | Leksell Gamma Knife Perfexion | Oct 29, 2015 | Substantially Equivalent |
| K151666 | Leksell GammaPlan | Sep 3, 2015 | Substantially Equivalent |
| K151561 | Leksell Gamma Knife Icon | Aug 4, 2015 | Substantially Equivalent |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | May 9, 2014 | Substantially Equivalent |