# K153009: ULTRA Telescopes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Apr 5, 2016 after 174 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 K944072 (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)
- K944072: Olympus Nasal and Sinus Endoscopes, Olympus America, Inc. (1995) Summary page 5.

## Indications for use
Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.

Source page: https://510kreport.com/device/K153009
Methodology: https://510kreport.com/methodology