# K170955: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
- Decided: Jul 3, 2017 after 94 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: 8 generations back to K970720 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 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.

## Indications for use
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices 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 Devices can be used to coagulate isolated vessels up to 5 mm diameter.

Source page: https://510kreport.com/device/K170955
Methodology: https://510kreport.com/methodology