# K172595: CUSA Excel+ Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Sep 28, 2017 after 30 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: 5 generations back to K884413 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150682: CUSA Excel+, Integra Lifesciences Corp. (2015) Summary page 4.

## Indications for use
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive 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 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 Gynecological Surgery — including removal of dysplastic genital or perianal epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

Source page: https://510kreport.com/device/K172595
Methodology: https://510kreport.com/methodology
