# K191715: Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 27, 2020 after 215 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: 1 generation back to K951104 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951104: Endoboot, United States Endoscopy Group, Inc. (1995) Summary page 5.

## Indications for use
The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

Source page: https://510kreport.com/device/K191715
Methodology: https://510kreport.com/methodology