# K173627: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Jul 12, 2018 after 230 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: 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 5.

## Indications for use
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 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 diameter. The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Source page: https://510kreport.com/device/K173627
Methodology: https://510kreport.com/methodology