FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
K Number: K051947
·
Decision Aug 22, 2005
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
- K Number
- K051947
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Date Received
- July 18, 2005
- Decision Date
- August 22, 2005
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
CUSA® Clarity Ultrasonic Surgical Aspirator System
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SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
FDA 510(k)
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Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
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Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Radionics, A Division of Tyco Healthcare Group LP
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | Mar 12, 2001 | Substantially Equivalent |