# K070815: THD

- Pathway: 510(k) (Traditional)
- Applicant: G.F. S.R.L.
- Decided: Jun 20, 2007 after 86 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: 3 generations back to K930458 (1995). 4 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K041915: Hemo-Dop, Dwl Elektronische Systeme GmbH (2004) Summary page 1.
- K052067: Doppler Guided Proctoscope, Model 500H, Multigon Industries, Inc. (2005) Summary page 1.

## Most influential descendants
- 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 THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and a needle holder included in the THD Kit. The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

Source page: https://510kreport.com/device/K070815
Methodology: https://510kreport.com/methodology