# K190643: Medline Electrocautery Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: May 6, 2019 after 54 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Medline Electrocautery Pencil is intended to be used in electrosurgical procedures to remove tissue and control bleeding by use of high frequency electrical current. The device can be used for both cutting and coagulating.

Source page: https://510kreport.com/device/K190643
Methodology: https://510kreport.com/methodology