# K962678: Bipolar Pencil Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Aug 14, 1996 after 35 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K024304: Microsurgical Bipolar Handpiece (2003), 2 descendants of its own
- K040584: NMX-1000 (2004), 1 descendant of its own
- K220891: Kahook Dual Blade Glide (KDB Glide) (2024), 0 descendants of its own
- K072911: Ion Medical Bipolar Coagulation Pen (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K962678
Methodology: https://510kreport.com/methodology