# K201832: Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 17, 2021 after 442 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: 10 generations back to K931154 (1993). 37 ancestors in all.
No later device cites it as a predicate yet.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190, Olympus Medical Systems Corp. (2013) Summary page 5.

## Recalls of this device
- Nov 20, 2023 · Class II · Z-0644-2024: 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 is intended 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 female reproductive organs.

Source page: https://510kreport.com/device/K201832
Methodology: https://510kreport.com/methodology