# K980895: Allegro Ultrasonic Soft Tissue Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: California Institute of Tissue Eng. & Instrumenti
- Decided: Nov 6, 1998 after 242 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: 2 generations back to K910696 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970471: Mentor Ultrasound Assisted Tissue Removal System (TRS), Mentor Corp. (1997) Summary page 2.
- K910696: Cusa (R) System 200C/200T/200M/200H Ultra Aspirator, Valleylab, Inc. (1991) Summary page 2.
- K971609: Sculpture, Servizi Medico Estetici Italinai Srl. (1997) Summary page 2.
- K962525: Ultra-Safe Ultrasonic Aspirator System, Morwel Corp. (1996) Summary page 2.

## Indications for use
The Allegro is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired. —General Surgery -Plastic and reconstructive Surgery

Source page: https://510kreport.com/device/K980895
Methodology: https://510kreport.com/methodology