# K260287: SP Electrocautery Device (SP20)

- Pathway: 510(k) (Special)
- Applicant: Single Pass, Inc.
- Decided: Feb 24, 2026 after 26 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
Longest line of descent: 3 generations back to K810017 (1981). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232805: Kronos Electrocautery Device, Single Pass, Inc. (2024) Summary page 5.

## Indications for use
The SP Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.

Source page: https://510kreport.com/device/K260287
Methodology: https://510kreport.com/methodology