# K030315: Modification to Ultroid Hemorrhoid Management System

- Pathway: 510(k) (Special)
- Applicant: Ultroid, LLC
- Decided: Feb 27, 2003 after 28 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, 11, I11 , IV.

Source page: https://510kreport.com/device/K030315
Methodology: https://510kreport.com/methodology