# K160249: ULTRA Telescopes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Apr 21, 2016 after 80 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K951354 (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)
- K951354: Olympus Arthroscopy System, Olympus America, Inc. (1995) Summary page 5.

## Indications for use
These devices are indicated for use in arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints such as the knee, shoulder, hip, ankle, foot, elbow.

Source page: https://510kreport.com/device/K160249
Methodology: https://510kreport.com/methodology