# K143562: Reprocessed Cordless Ultrasonic Dissection Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: May 20, 2015 after 155 days
- Product code: NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments)
- 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: 9 generations back to K970720 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 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 5.
- K141371: Sonicision Cordless Ultrasonic Dissector, Covidien, Formerly Valleylab, A Division of Tyco H (2014) Summary page 5.

## Indications for use
The reprocessed cordless ultrasonic dissection devices are intended to be used for cutting soft tissue when control of bleeding and minimal thermal injury is desired. The devices can be used to coagulate isolated vessels up to 5 mm. The instruments 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.

Source page: https://510kreport.com/device/K143562
Methodology: https://510kreport.com/methodology