# K192963: Kogent Torus Ultrasonic Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Katalyst Surgical, LLC
- Decided: Jun 19, 2020 after 240 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010309 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190070: Sonopet iQ Ultrasonic Aspirator System, Stryker Corporation (2019) Summary page 5.
- K010309: Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator, Mutoh America Co., Ltd. (2001) Summary page 5.

## Indications for use
The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery.

Source page: https://510kreport.com/device/K192963
Methodology: https://510kreport.com/methodology