510(k) K261361 ยท LFL Instrument, Ultrasonic Surgical
TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)
| Applicant | Carl Zeiss Meditec, AG, Oberkochen, DE |
| Decision | Substantially Equivalent, Oct 15, 2026 |
| Received | Apr 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261361
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.