# K180149: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Mar 26, 2018 after 66 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K936109 (1994). 119 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101797: Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision Sterilization T, Covidien, Formerly Valleylab, A Division of Tyco (2011) Summary page 4.
- K153371: Sonicision Cordless Ultrasonic Dissection Device, Covidien, LLC (2016) Summary page 4.
- K141371: Sonicision Cordless Ultrasonic Dissector, Covidien, Formerly Valleylab, A Division of Tyco H (2014) Summary page 4.

## Most influential descendants
- K212301: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (2021), 0 descendants of its own

## Recalls of this device
- Nov 12, 2021 · Class II · Z-0332-2022: Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
- Jun 23, 2021 · Class II · Z-2240-2021: Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue da

## Indications for use
The Sonicision™ Curved Jaw 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 and including 5 mm in diameter. The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Source page: https://510kreport.com/device/K180149
Methodology: https://510kreport.com/methodology