# K971341: Kirwan Model 28 1000 Bipolar Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: May 22, 1997 after 42 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.
978 later devices descend from it; 1 cites it directly.
0 of 979 devices 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.

## Most influential descendants
- K974521: Vnus Closure System (1998), 977 descendants of its own
- K982816: Vnus Closure System (1999), 973 descendants of its own
- K012398: Diomed 15 Diode Laser (2002), 714 descendants of its own
- K022266: Aurora SR (2002), 705 descendants of its own
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own

## Indications for use
The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

Source page: https://510kreport.com/device/K971341
Methodology: https://510kreport.com/methodology