# K190281: Ultrasonic Surgical System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medisonic Technology CO
- Decided: Oct 31, 2019 after 262 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: 9 generations back to K862807 (1986). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172464: XD880A Ultrasonic Osteotomy Surgical System, Morley Research Consortium (2018) Summary page 4.

## Indications for use
Ultrasonic Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: • Otolaryngology • Oral/maxillofacial • Hand and foot • Neurosurgery • Spine • Plastic/reconstructive.

Source page: https://510kreport.com/device/K190281
Methodology: https://510kreport.com/methodology