FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSA Clarity Ultrasonic Surgical Aspirator System
K Number: K221835
·
Decision Aug 22, 2022
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
65
Review Days
60
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Basic Information
- Device Name
- CUSA Clarity Ultrasonic Surgical Aspirator System
- K Number
- K221835
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- June 23, 2022
- Decision Date
- August 22, 2022
- 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 Integra LifeSciences Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Oct 8, 2025 | Substantially Equivalent |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Apr 9, 2025 | Substantially Equivalent |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2024 | Substantially Equivalent |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2023 | Substantially Equivalent |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 15, 2022 | Substantially Equivalent |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | Oct 8, 2021 | Substantially Equivalent |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | Jul 27, 2021 | Substantially Equivalent |
| K193346 | Codman Surgical Patties & Strips | Nov 20, 2020 | Substantially Equivalent |
| K201507 | Cadence Total Ankle System | Jun 29, 2020 | Substantially Equivalent |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jun 23, 2020 | Substantially Equivalent |