# K023706: Ultroid Hemorrhoid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Ultroid, LLC
- Decided: Jan 14, 2003 after 71 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 4 (0 Class I)
- 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.

## Recalls of this device
- Oct 19, 2016 · Class II · Z-0785-2017: Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidanc
- Oct 19, 2016 · Class II · Z-0782-2017: Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidanc
- Oct 19, 2016 · Class II · Z-0783-2017: Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidanc
- Oct 19, 2016 · Class II · Z-0784-2017: Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidanc

## Indications for use
The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, II, III, IV.

Source page: https://510kreport.com/device/K023706
Methodology: https://510kreport.com/methodology