Cleared Traditional

Kogent Torus Ultrasonic Aspirator (K192963) - FDA 510(k) Clearance

K192963 · Katalyst Surgical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
240d
Days
-
Risk

K192963 is an FDA 510(k) clearance for the Kogent Torus Ultrasonic Aspirator. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on June 19, 2020 after a review of 240 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.

View all Katalyst Surgical, LLC devices

Submission Details

510(k) Number K192963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2019
Decision Date June 19, 2020
Days to Decision 240 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 115d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 53
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K192963.
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Sonicision Cordless Ultrasonic Dissector
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CUSA Clarity Ultrasonic Surgical Aspirator System
K200774 · Integra LifeSciences Corporation · Jun 2020
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
K191555 · Ethicon Endo-Surgery, LLC · Feb 2020
Ultrasonic Surgical System
K190281 · Medisonic Technology CO · Oct 2019
neXus Ultrasonic Surgical Aspirator System
K190160 · Misonix, Inc. · May 2019