510(k) clearance

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)

FDA 510(k) source

510(k) number

K261361

Applicant

Carl Zeiss Meditec, AG

Decision date

Oct 15, 2026

Date received

Apr 27, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LFL

Device type

Instrument, Ultrasonic Surgical

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Oberkochen, DE