# K024138: Heat Scissors Generator Set and Heat Scissors Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Mar 12, 2003 after 86 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K982289: Heat Probe Unit Hpu-20, Heat Probe CD-110##/120##, Olympus America, Inc. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K902307: Shaw II Hemostatic Surgery System, Hemostatic Surgery Corp. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K990728: Thermal Cautery Device, Forceps, Starion Instruments (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue. The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.

Source page: https://510kreport.com/device/K024138
Methodology: https://510kreport.com/methodology