# K994130: Rectosight RS 300-04

- Pathway: 510(k) (Traditional)
- Applicant: Sightline Technologies, Ltd.
- Decided: Jun 30, 2000 after 206 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.
39 later devices descend from it; 1 cites it directly.
0 of 40 devices 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.

## Most influential descendants
- K032688: Colonosight Model 510B (2004), 38 descendants of its own
- K091305: Clearpath (2009), 13 descendants of its own
- K052930: Navigator Endoscopy System (2006), 13 descendants of its own
- K070622: Neoguide Endoscopy System (2007), 12 descendants of its own
- K093779: Clearpath Ugi (2010), 10 descendants of its own

## Indications for use
The RectoSight® RS 300-04 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® PS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the anal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures

Source page: https://510kreport.com/device/K994130
Methodology: https://510kreport.com/methodology