# K223770: Sonopet 1Q 3 7cm 1Q Large

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Feb 16, 2023 after 63 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 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable. The 37em iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general 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/K223770
Methodology: https://510kreport.com/methodology