# K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Sep 29, 2009 after 63 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- 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.
22 later devices descend from it; 3 cite it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System, Acmi Corporation (2006) Summary page 2.
- K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System, Gyrus Acmi, Inc. (2007) Summary page 2.
- K990411: MVM 7.5 French Flexible Hysteroscope, Karl Storz Endoscopy (1999) Summary page 2.
- K022445: Visera Hysterovideoscope Olympus Hyf Type V, Olympus Optical Co., Ltd. (2003) Summary page 2.

## Most influential descendants
- 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
- K183020: Endosee System (2019), 4 descendants of its own

## Indications for use
The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invisio TM Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color. Diagnostic Hysteroscopy: Abnormal uterine bleeding Infertility & pregnancy wastage Evaluation of abnormal hysterosalpingogram Intrauterine foreign body Amenorrhea Pelvic pain Operative Hysteroscopy: Directed biopsy Removal of fibroids and polyps Transection of intrauterine adhesions Transection intrauterine septa

Source page: https://510kreport.com/device/K092278
Methodology: https://510kreport.com/methodology