FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K Number: K010548
·
Decision Mar 12, 2001
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
8
Review Days
14
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Basic Information
- Device Name
- MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
- K Number
- K010548
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Date Received
- February 26, 2001
- Decision Date
- March 12, 2001
- 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 |
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Other Clearances by Radionics, A Division of Tyco Healthcare Group LP
| K Number | Device Name | ||
|---|---|---|---|
| K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | Aug 22, 2005 | Substantially Equivalent |
| K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE | Aug 27, 2004 | Substantially Equivalent |
| K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE | Sep 15, 2003 | Substantially Equivalent |
| K023519 | RADIONICS VARILINK 2 | Jan 16, 2003 | Substantially Equivalent |
| K021942 | RADIONICS POLE NEEDLES | Sep 11, 2002 | Substantially Equivalent |
| K013661 | XPLAN 2.2 WITH THE BODY SYSTEM | Dec 3, 2001 | Substantially Equivalent |
| K012850 | RECORDING AND STIMULATING ELECTRODE | Nov 19, 2001 | Substantially Equivalent |