# K013668: Berchtold Elektrotom 106 Hitt

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Corp.
- Decided: Feb 4, 2002 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This device is intended for the coagulation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Source page: https://510kreport.com/device/K013668
Methodology: https://510kreport.com/methodology