# K964601: Cusa System 200C Ultrasonic Aspirator/Cusa System 200T Ultrasonic Aspirator/Cusa Lap Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Jan 16, 1997 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The CUSA System 200 with Soft Start, and the CUSA Lap™ Accessory are to be used during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable.

Source page: https://510kreport.com/device/K964601
Methodology: https://510kreport.com/methodology