# K011825: Rectosight RS300-04;and Protosight PS300-04 Device

- Pathway: 510(k) (Special)
- Applicant: Sightline Technologies, Ltd.
- Decided: Jul 11, 2001 after 30 days
- Product code: FER (Anoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RectoSight® RS300-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures. The ProctoSight® PS310-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.

Source page: https://510kreport.com/device/K011825
Methodology: https://510kreport.com/methodology