# K200427: Sonicision Cordless Ultrasonic Dissector

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Jul 10, 2020 after 140 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: 15 generations back to K936109 (1994). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153371: Sonicision Cordless Ultrasonic Dissection Device, Covidien, LLC (2016) Summary page 4.

## Indications for use
The Sonicision™ cordless ultrasonic dissection device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision™ cordless ultrasonic dissection device can be used to coagulate isolated vessels up to 5 mm in diameter. The Sonicision™ 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Source page: https://510kreport.com/device/K200427
Methodology: https://510kreport.com/methodology