# K230427: CUSA Clarity Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Jul 11, 2023 after 144 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: 8 generations back to K884413 (1988). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190180: CUSA Clarity Ultrasonic Surgical Aspirator System, Integra LifeSciences Corporation (2019) Summary page 4.

## Indications for use
The CUSA Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Neurosurgery – including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas 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 or hard 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/K230427
Methodology: https://510kreport.com/methodology