510(k) K161882 ยท LFL Instrument, Ultrasonic Surgical
CUSA Clarity Ultrasonic Surgical Aspirator System
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Jul 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2026 | Integra LifeSciences Corp. (NeuroSciences) CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. Open, Classified |
LFL | None listed |
| Sep 26, 2017 | Integra LifeSciences Corp. Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000
Product Usage:
The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.