# K960040: Sharplan Ultra Laparoscopic Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Apr 29, 1996 after 118 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: 1 generation back to K883091 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921251: Cusa System 200C and 200T Ultrasonic Aspirator, Valleylab, Inc. (1992) Summary page 1.
- K883091: Sharplan 4300 & 4310 Ultrasonic Surgical Apirators, Sharplan Lasers, Inc. (1988) Summary page 1.

## Indications for use
It is indicated for use in laparoscopic surgical procedures where fragmentation, emulsification, and aspiration of soft is desirable.

Source page: https://510kreport.com/device/K960040
Methodology: https://510kreport.com/methodology