# K090864: Cusa  Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Integra Radionics, Inc.
- Decided: May 8, 2009 after 39 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 1.
- K051947: Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone, Radionics, A Division of Tyco Healthcare Group LP (2005) Summary page 1.
- K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System, Integra Radionics, Inc. (2008) Summary page 1.

## Indications for use
The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, 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/K090864
Methodology: https://510kreport.com/methodology