# K221557: Visera Hysterovideoscope Olympus HYF Type V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 2, 2022 after 94 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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: 2 generations back to K891451 (1989). 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)
- K022445: Visera Hysterovideoscope Olympus Hyf Type V, Olympus Optical Co., Ltd. (2003) Summary page 5.

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0336-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Jul 20, 2023 · Class II · Z-2480-2023: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

## Indications for use
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.

Source page: https://510kreport.com/device/K221557
Methodology: https://510kreport.com/methodology