# K050253: Usgi Shapelock Endoscopic Guide

- Pathway: 510(k) (Special)
- Applicant: Usgi Medical
- Decided: Feb 28, 2005 after 25 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
The USGI ShapeLock Endoscopic Guide is intented to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

Source page: https://510kreport.com/device/K050253
Methodology: https://510kreport.com/methodology