# K051919: Modification to:  Usgi Shapelock Endoscopic Guide

- Pathway: 510(k) (Special)
- Applicant: Usgi Medical
- Decided: Jul 26, 2005 after 11 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. The FDA summary names no predicate by number.

## Indications for use
The USGI ShapeLock Endoscopic Guide is intended to be used with an endoscope to to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

Source page: https://510kreport.com/device/K051919
Methodology: https://510kreport.com/methodology