# K022445: Visera Hysterovideoscope Olympus Hyf Type V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Jan 24, 2003 after 183 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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: 1 generation back to K891451 (1989). 1 ancestor in all.
24 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891451: Olympus Hyf-P Flexible Hysterofiberscope, Olympus Corp. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories, Olympus America, Inc. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 (2009), 22 descendants of its own
- K123151: Endosee Model 8000 U-Scope (2013), 20 descendants of its own
- K132384: U-Scope 8000 System with HSC+Emb Cannula (2014), 19 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K202445: Hystero-V Hysteroscope (2021), 4 descendants of its own

## Recalls of this device
- 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
This instrument 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, including: - Abnormal uterine bleeding - Evaluation of'abnormal hysterosalpingogram - Evaluation of abnormal ultrasound image - Infertility and pregnancy wastage - Pelvic pain

Source page: https://510kreport.com/device/K022445
Methodology: https://510kreport.com/methodology