Cleared Traditional

K261361 - TORUS Ultrasonic Aspirator System

Also marketed or referenced as:
and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)
K261361 · Carl Zeiss Meditec, AG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
171d
Days
-
Risk

K261361 is an FDA 510(k) clearance for the TORUS Ultrasonic Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Carl Zeiss Meditec, AG (Oberkochen, DE). The FDA issued a Cleared decision on October 15, 2026 after a review of 171 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K261361

510(k) Number K261361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date October 15, 2026
Days to Decision 171 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 159
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K261361.
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K262244 · Stryker Instruments · Oct 2026
neXus Ultrasonic Surgical Aspirator System
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K251162 · Integra LifeSciences Corporation · Oct 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
K261361 · TORUS Ultrasonic Aspirator System
Download PDF FDA Summary Carl Zeiss Meditec, AG