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The Tracker / October 2026 / K261361

510(k) cleared

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)

Carl Zeiss Meditec, AG · Oct 15, 2026 · K261361

FDA cleared the 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) from Carl Zeiss Meditec, AG on Oct 15, 2026 under K261361, a traditional 510(k). The device falls under product code LFL, Instrument, Ultrasonic Surgical as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 27, 2026. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carl Zeiss Meditec, AG has 3 other decisions in the tracker over the last 12 months: K262097 (MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)), K260694 (ZEISS CLINIC 360), K253834 (VISUREF 600).

Questions & Answers

What did FDA clear under K261361?

K261361 is the FDA 510(k) for 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), submitted by Carl Zeiss Meditec, AG. FDA's decision date was Oct 15, 2026, under product code LFL (Instrument, Ultrasonic Surgical).

Who makes the 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)?

Carl Zeiss Meditec, AG, based in Oberkochen, is the applicant of record for K261361.

How long did the K261361 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Oct 15, 2026, 171 days later.

← All decisions in October 2026

Sources