# K141674: Cusa Excel+ Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Nov 6, 2014 after 136 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K884413 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System, Valleylab, Inc. (1998) Summary page 4.
- K051947: Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone, Radionics, A Division of Tyco Healthcare Group LP (2005) Summary page 4.

## Recalls of this device
- May 29, 2024 · Class II · Z-2167-2024: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

## Indications for use
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: * Neurosurgery » Gastrointestinal and Affiliated Organ Surgery » Urological Surgery » Plastic and Reconstructive Surgery * General Surgery * Orthopedic Surgery * Gynecological Surgery * Thoracic Surgery » Laparoscopic Surgery » Thoracoscopic Surgery

Source page: https://510kreport.com/device/K141674
Methodology: https://510kreport.com/methodology