# K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 20, 2012 after 333 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: 8 generations back to K931154 (1993). 29 ancestors in all.
34 later devices descend from it; 6 cite it directly.
3 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080948: HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH, Olympus Medical Systems Corporation (2008)
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 2.
- K062049: Evis Exera II 180 System, Olympus Medical Systems Corporation (2006) Summary page 2.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 2.

## Most influential descendants
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 (2013), 19 descendants of its own
- K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link (2015), 7 descendants of its own
- K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (2023), 5 descendants of its own
- K201526: TIPCAM1 Rubina Video Endoscope System (2020), 5 descendants of its own
- K193026: Visera Elite II Video System Center, Visera Elite II Endoeye 3D (2020), 5 descendants of its own

## Recalls of this device
- Nov 20, 2023 · Class II · Z-0645-2024: Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videosc

## Indications for use
This instrument has been designed to be used with a video system center, light source, dlocumentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. This instrument must not to be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart. This video system center has been designed to be used with OLYMPUS camera heads, endloscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Source page: https://510kreport.com/device/K111425
Methodology: https://510kreport.com/methodology