# K001407: Surgitron Iec II

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Jul 24, 2000 after 81 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K012799: ES-2000 Shape Select Electrosurgical Scalpel (2001), 2 descendants of its own
- K070275: Flexible Loop Electrosurgical Electrode (2007), 0 descendants of its own
- K030473: Senorx ES-300 (2003), 0 descendants of its own
- K021707: Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders (2002), 0 descendants of its own
- K012129: Ortho Development Orion-I Emf System (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K001407
Methodology: https://510kreport.com/methodology