# K001253: Surgitron Iec II

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: May 26, 2000 after 37 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.
220 later devices descend from it; 4 cite it directly.
0 of 221 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014290: Entec Plasma Wands (2002), 119 descendants of its own
- K013255: Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF (2001), 104 descendants of its own
- K021364: Modification to Entec Plasma Wands (2002), 94 descendants of its own
- K030108: Arthrocare Ent Coblator Surgery System (2003), 92 descendants of its own
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), 76 descendants of its own

Source page: https://510kreport.com/device/K001253
Methodology: https://510kreport.com/methodology