# K191011: Scope ProTech

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Endoscopy, Ltd.
- Decided: May 7, 2019 after 21 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K202838: Andorate Universal Endoscope Tip Guard (2021), 0 descendants of its own

## Indications for use
The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm-14.7mm. The Scope ProTech will aid in the protection of distal end, the lens and other delicate components from damage. It is not intended for use during sterilization.

Source page: https://510kreport.com/device/K191011
Methodology: https://510kreport.com/methodology