# K112400: Smartshears

- Pathway: 510(k) (Traditional)
- Applicant: Nuscience Consulting and Management Group, LLC
- Decided: Sep 12, 2011 after 24 days
- Product code: FZT (Cutter, Surgical)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K821116 (1982). 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)
- K821116: Lister Bandage Scissors 5 & 1/2, Conphar, Inc. (1982) Summary page 1.

## Indications for use
SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.

Source page: https://510kreport.com/device/K112400
Methodology: https://510kreport.com/methodology