FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSA® Clarity Ultrasonic Surgical Aspirator System
K Number: K251162
·
Decision Oct 8, 2025
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
65
Review Days
176
Basic Information
- Device Name
- CUSA® Clarity Ultrasonic Surgical Aspirator System
- K Number
- K251162
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- April 15, 2025
- Decision Date
- October 8, 2025
- 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.
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
CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Integra LifeSciences Corporation
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Aug 22, 2022 | 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 |