# K090980: HD Endoeye, Models WA50011A, WA50013A, WA50013L, WA50013T, WA50015L

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jun 29, 2009 after 83 days
- Product code: NWB (Endoscope, Accessories, Narrow Band Spectrum)
- 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 K955456 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955456: Oes Laparo-Thoraco Videoscope (Rigid), Olympus America, Inc. (1996) Summary page 2.
- K080948: HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH, Olympus Medical Systems Corporation (2008) Summary page 2.

## Indications for use
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrsurgical unit and other ancillary equipment for endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.

Source page: https://510kreport.com/device/K090980
Methodology: https://510kreport.com/methodology