# K190744: Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)

- Pathway: 510(k) (Special)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Aug 29, 2019 after 160 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955456 (1996). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111788: Endoeye HD II, Olympus America, Inc. (2012) Summary page 4.

## Most influential descendants
- K193026: Visera Elite II Video System Center, Visera Elite II Endoeye 3D (2020), 5 descendants of its own
- K201200: Visera Elite II Video System Center (2020), 4 descendants of its own
- K242067: Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA (2025), 2 descendants of its own
- K262079: 4K Camera Head OLYMPUS CH-S700-08-LB (2026), 0 descendants of its own
- K251336: VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (2025), 0 descendants of its own

## Recalls of this device
- Nov 6, 2023 · Class II · Z-0697-2024: Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal inju

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

Source page: https://510kreport.com/device/K190744
Methodology: https://510kreport.com/methodology