CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k) clearance K161882 · decided 2016-10-14
Clearance details
- K-number
- K161882
- Device name
- CUSA Clarity Ultrasonic Surgical Aspirator System
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-07-11
- Decision date
- 2016-10-14
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator sys recall (Z-1828-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-04-17 |