# K062257: Starion Instruments Thermal Litigating Shears

- Pathway: 510(k) (Special)
- Applicant: Starion Instruments
- Decided: Oct 10, 2006 after 67 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002547 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002547: Starion Instruments Power Point Cautery Grasper/Dissector, Starion Instruments (2000) Summary page 1.

## Most influential descendants
- K124029: Microline Flexible Ligating Shears (2013), 0 descendants of its own
- K122086: Thermal Ligating Shears (2012), 0 descendants of its own

## Recalls of this device
- Mar 22, 2019 · Class II · Z-1698-2019: The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
- Mar 9, 2010 · Not classified · Z-2239-2010: The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also 
- Jun 26, 2008 · Not classified · Z-1972-2010: Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.

## Indications for use
For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.

Source page: https://510kreport.com/device/K062257
Methodology: https://510kreport.com/methodology