# K173889: Medline Cautery Electrode (PTFE)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 9, 2018 after 109 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 PTFE Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

Source page: https://510kreport.com/device/K173889
Methodology: https://510kreport.com/methodology