# K980930: Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta

- Pathway: 510(k) (Traditional)
- Applicant: Fibra Sonics, Inc.
- Decided: Sep 22, 1998 after 194 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues s used in the following surgical areas: (a) Neurosurgery (b) Gastrointestinal and affiliated organ surgery {c) Urological surgery (d) Plastic and reconstructive surgery (e} Gynecological procedures (f) Orthopedic Surgery These indicated uses are equivalent to the predicate device. Appropriate warnings and cautions are indicated in the Operator’s Manual.

Source page: https://510kreport.com/device/K980930
Methodology: https://510kreport.com/methodology