# K170054: iSurg

- Pathway: 510(k) (Abbreviated)
- Applicant: Jaco, LLC Dba Macan Manufacturing and Bna Burz North America
- Decided: Oct 2, 2017 after 269 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: 6 generations back to K933002 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170107: Surgi Max Ultra, Elliquence, LLC (2017). Cleared while this submission was under review Summary page 5.
- K050735: MC6A, Macan Engineering Co. (2005) Summary page 5.

## Indications for use
Cutting and coagulation of skin.

Source page: https://510kreport.com/device/K170054
Methodology: https://510kreport.com/methodology