# K972311: Model 20 Bipolar Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Boston Surgical Products, Inc.
- Decided: Sep 18, 1997 after 90 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K830863: Hancock Pericardial Patch, Extracorporeal Medical Specialities, Inc. (1983). Our OCR of the scanned summary read K830863, FDA’s number for Hancock Pericardial Patch (Extracorporeal Medical Specialities, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Kirwan Model 25 1000”. Kept off the family tree.

## Indications for use
The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.

Source page: https://510kreport.com/device/K972311
Methodology: https://510kreport.com/methodology