# K111788: Endoeye HD II

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jan 13, 2012 after 203 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: 2 (0 Class I)
- 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.
10 later devices descend from it; 4 cite it directly.
0 of 13 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 3.
- K080948: HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH, Olympus Medical Systems Corporation (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- K095998: HD EndoEYE. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K190744: Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A) (2019), 6 descendants of its own
- 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
- K190190: WV1 Endoscope (2019), 1 descendant of its own

## Recalls of this device
- Feb 10, 2017 · Class II · Z-1929-2017: A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
- Nov 17, 2015 · Class II · Z-0403-2016: A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.

## 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/K111788
Methodology: https://510kreport.com/methodology