# K171208: Trans-anal Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Feb 5, 2018 after 286 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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
Intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon. Use of device is limited to non-sterile procedures or procedures where non-sterile laparoscopes are used.

Source page: https://510kreport.com/device/K171208
Methodology: https://510kreport.com/methodology