# K243930: Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Mar 24, 2025 after 94 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 K190070 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213824: Sonopet iQ Ultrasonic Aspirator System, Stryker Corporation (2022) Summary page 5.

## Indications for use
The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue and hard tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated Organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery. CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

Source page: https://510kreport.com/device/K243930
Methodology: https://510kreport.com/methodology