# K970039: Encore Electrosurgical Handcontrol Pencil (35001-001)

- Pathway: 510(k) (Traditional)
- Applicant: Medtrex, Inc.
- Decided: Feb 26, 1997 after 51 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983761: Aaron Electrosurgical Handcontrol Pencil, Model ESP5 (1998), 1 descendant of its own
- K991669: PMS 750 Fingerswitch (1999), 0 descendants of its own
- K984352: Aaron TOP50 Reusable Electrosurgical Pencil, Model #Espr (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K970039
Methodology: https://510kreport.com/methodology