# K072911: Ion Medical Bipolar Coagulation Pen

- Pathway: 510(k) (Traditional)
- Applicant: Ion Medical, LLC
- Decided: Dec 13, 2007 after 62 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
Longest line of descent: 1 generation back to K911160 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962678: Bipolar Pencil Coagulator, Kirwan Surgical Products, Inc. (1996) Summary page 1.
- K911160: Mentor (R) Wet-Field (R) II AC Coagulator, 22-1305, Mentor O & O, Inc. (1991) Summary page 1.

## Indications for use
The Ion Medical Bipolar Coagulation Pen is a single use instrument intended to coagulate tissue using radiofrequency electric current during general and ophthalmic surgical procedures where wet field conditions exist.

Source page: https://510kreport.com/device/K072911
Methodology: https://510kreport.com/methodology