# K101797: Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision Sterilization T

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Valleylab, A Division of Tyco
- Decided: Feb 24, 2011 after 241 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: 7 generations back to K970720 (1997). 34 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.
- K042777: Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P, Ethicon Endo-Surgery, Inc. (2004) Summary page 1.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.
- K071708: I45, I45S, I60, and I60S, Power Medical Interventions, Inc. (2007) Summary page 1.

## Most influential descendants
- K141371: Sonicision Cordless Ultrasonic Dissector (2014), 3 descendants of its own
- K180149: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide (2018), 1 descendant of its own
- K212301: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (2021), 0 descendants of its own
- K170955: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (2017), 0 descendants of its own
- K143562: Reprocessed Cordless Ultrasonic Dissection Device (2015), 0 descendants of its own

## Indications for use
The SonicisionTM 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.

Source page: https://510kreport.com/device/K101797
Methodology: https://510kreport.com/methodology