# K960020: Solo Band Ligator

- Pathway: 510(k) (Traditional)
- Applicant: Surcraft, LLC
- Decided: Apr 1, 1996 after 90 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
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. The FDA summary names its predicate without a number.
- (no number) McGivney hemorrhoid ligator: named in the summary without a submission number
- (no number) Hirschman anoscope: named in the summary without a submission number
- (no number) Brinkerhof rectal speculum: named in the summary without a submission number

## Indications for use
The new device is therefor a socalled “combination” devise that claims to have the same intended uses as several different types of predicate devices

Source page: https://510kreport.com/device/K960020
Methodology: https://510kreport.com/methodology