FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
neXus Ultrasonic Surgical Aspirator System
K Number: K190160
·
Decision May 30, 2019
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
17
Review Days
120
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
- neXus Ultrasonic Surgical Aspirator System
- K Number
- K190160
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Misonix, Inc.
- Date Received
- January 30, 2019
- Decision Date
- May 30, 2019
- 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
FDA 510(k)
FDA Unclassified
·Unknown
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)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
·Unknown
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 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 |
| 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 |
| K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | May 11, 2007 | 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 |