FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K Number: K070313
·
Decision May 11, 2007
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
17
Review Days
99
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Basic Information
- Device Name
- MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K Number
- K070313
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Misonix, Inc.
- Date Received
- February 1, 2007
- Decision Date
- May 11, 2007
- 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 |
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Other Clearances by Misonix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221235 | neXus Ultrasonic Surgical Aspirator System | Jul 28, 2022 | Substantially Equivalent |
| K212060 | neXus Ultrasonic Surgical Aspirator System | Dec 13, 2021 | Substantially Equivalent |
| K190160 | neXus Ultrasonic Surgical Aspirator System | May 30, 2019 | Substantially Equivalent |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Mar 5, 2013 | Substantially Equivalent |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Dec 1, 2011 | Substantially Equivalent |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Jul 9, 2008 | Substantially Equivalent |
| K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | Oct 26, 2006 | Substantially Equivalent |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Jan 26, 2006 | Substantially Equivalent |
| K052702 | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY | Nov 21, 2005 | Substantially Equivalent |
| K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jun 6, 2005 | Substantially Equivalent |