# K151191: OES ELITE Telescopes, Protective Tube

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Nov 24, 2015 after 204 days
- Product code: FBP (Telescope, Rigid, Endoscopic)
- 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 K923982 (1993). 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)
- K923982: Olympus Oes Laparoscopy System, Olympus Corp. (1993) Summary page 5.

## Indications for use
The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures. The device is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Source page: https://510kreport.com/device/K151191
Methodology: https://510kreport.com/methodology