# K161882: CUSA Clarity Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Oct 14, 2016 after 95 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K884413 (1988). 17 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141668: Cusa Excel+ Ultrasonic Surgical Aspirator System, Integra LifeSciences Corporation (2014) Summary page 4.
- K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System, Integra Radionics, Inc. (2008) Summary page 4.

## Most influential descendants
- K182809: CUSA Clarity Ultrasonic Surgical Aspirator System (2018), 10 descendants of its own
- K200774: CUSA Clarity Ultrasonic Surgical Aspirator System (2020), 5 descendants of its own
- K221235: neXus Ultrasonic Surgical Aspirator System (2022), 2 descendants of its own
- K231117: neXus Ultrasonic Surgical Aspirator System (2023), 1 descendant of its own
- K190180: CUSA Clarity Ultrasonic Surgical Aspirator System (2019), 1 descendant of its own

## Recalls of this device
- Mar 6, 2026 · Class II · Z-1828-2026: Software issue that renders the touch screen unresponsive.
- Sep 26, 2017 · Class II · Z-0694-2018: A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at

## Indications for use
The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Gastrointestinal and Affiliated Organ Surgery — including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery — including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Source page: https://510kreport.com/device/K161882
Methodology: https://510kreport.com/methodology