# K983199: Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model

- Pathway: 510(k) (Traditional)
- Applicant: Fibra Sonics, Inc.
- Decided: Dec 14, 1998 after 91 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 as used in the following surgical areas: NEUROSURGERY For the ablation and aspiration of various intracranial and spinal cord soft tissue tumors, which may include but are not necessarily limited to the following: Astrocytoma Pituitary adeonoma Acoustic neuroma Meningioma Glioma Brain stem tumors Spinal cord tumors. GASTROENTEROLOGY Various Gastroenterological and General surgery procedures along the GI tract, Wthh may include, but are not necessarily limited to the following: Hepatic resection Liver trauma Hepatic cysts Colon cancer Rectal Tumor Bowel tumor Retropertioneal tumor ORTHOPEDICS Various orthopedic procedures which may include, but are not necessarily limited to the following: Discectomy

Source page: https://510kreport.com/device/K983199
Methodology: https://510kreport.com/methodology