# K093079: Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model 4581-U

- Pathway: 510(k) (Traditional)
- Applicant: Hobbs Medical, Inc.
- Decided: Aug 2, 2010 after 306 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The TouchSoft™ Coagulator is used to provide therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

Source page: https://510kreport.com/device/K093079
Methodology: https://510kreport.com/methodology