# K032690: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: Dec 9, 2003 after 98 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 its predicate without a number.
- (no number) ValleyLab CUSA® EXCEL Ultrasonic Surgical Aspirator: named in the summary without a submission number
- (no number) Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator: named in the summary without a submission number

## Indications for use
The Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF Surgery interface components.

Source page: https://510kreport.com/device/K032690
Methodology: https://510kreport.com/methodology