# K982176: Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Sep 18, 1998 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K012129: Ortho Development Orion-I Emf System (2001), 0 descendants of its own

## Indications for use
The Kirwan Model 28 1500 Generator is a general purpose solid state monopolar generator with independent 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/K982176
Methodology: https://510kreport.com/methodology