CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k) clearance K251162 · decided 2025-10-08
Clearance details
- K-number
- K251162
- Device name
- CUSA® Clarity Ultrasonic Surgical Aspirator System
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-04-15
- Decision date
- 2025-10-08
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.