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CUSA® Selector®
INTEGRA LIFESCIENCES (IRELAND) LIMITED · Model 1523225 · UDI-DI 10381780025535
LFL
Prescription
10
510(k) clearances
68,850
Adverse events (81 deaths)
109
Recalls
141
Facilities
Description
The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-06 | Integra LifeSciences Corp. (NeuroSciences) | Software issue that renders the touch screen unresponsive. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
| 2025-10-22 | Olympus Corporation of the Americas | Firm is initiating a removal due to continued reports of adverse events. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.