# K124033: Medisiss Reprocessed Ultrasonic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instruments Service and Savings, Inc.
- Decided: Jan 7, 2014 after 375 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: 13 generations back to K936109 (1994). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100597: Harmonic Focus Shears, Ethicon Endo-Surgery, LLC (2010) Summary page 1.
- 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 MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.

Source page: https://510kreport.com/device/K124033
Methodology: https://510kreport.com/methodology