# K202838: Andorate Universal Endoscope Tip Guard

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Mar 5, 2021 after 161 days
- Product code: OCU (Endoscopic Storage Cover)
- 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
Longest line of descent: 2 generations back to K951104 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191011: Scope ProTech, Meditech Endoscopy, Ltd. (2019) Summary page 5.

## Indications for use
The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

Source page: https://510kreport.com/device/K202838
Methodology: https://510kreport.com/methodology