# K052067: Doppler Guided Proctoscope, Model 500H

- Pathway: 510(k) (Traditional)
- Applicant: Multigon Industries, Inc.
- Decided: Aug 29, 2005 after 28 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930458 (1995). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951449: Model KM-25, Koven Technology, Inc. (1996) Summary page 2.
- K041915: Hemo-Dop, Dwl Elektronische Systeme GmbH (2004) Summary page 2.

## Most influential descendants
- K070815: THD (2007), 4 descendants of its own
- K081429: THD Slide (2008), 3 descendants of its own
- K090009: THD Slide One (2009), 1 descendant of its own
- K150718: Wi-3 HAL-RAR System (2015), 0 descendants of its own
- K141657: THD Revolution (2015), 0 descendants of its own

## Indications for use
The Model 500H Doppler Guided Proctoscope is used to detect blood vessels supplying hemorrhoids and for performing HAL (Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders.

Source page: https://510kreport.com/device/K052067
Methodology: https://510kreport.com/methodology