# K100537: Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: May 12, 2010 after 76 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: 1 generation back to K063192 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063192: Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip, Ethicon Endo-Surgery, LLC (2007) Summary page 1.

## Indications for use
The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is 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 and other open procedures.

Source page: https://510kreport.com/device/K100537
Methodology: https://510kreport.com/methodology