# K093497: THD Bandy

- Pathway: 510(k) (Traditional)
- Applicant: Thd Spa
- Decided: Jul 15, 2010 after 245 days
- Product code: FHN (Ligator, Hemorrhoidal)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K993738 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070881: Lem Hemorrhoidal Ligator, Models a.5650, a.5660, Sapimed S.P.A. (2007) Summary page 1.
- K091519: Haemoband Multi-Ligator, Haemoband Surgical, Ltd. (2009) Summary page 1.
- K080132: THD Disposable Anoscope/Proctoscope, Thd Spa (2008) Summary page 1.

## Indications for use
The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in proctology procedures.

Source page: https://510kreport.com/device/K093497
Methodology: https://510kreport.com/methodology