# K093218: Femeye Two

- Pathway: 510(k) (Traditional)
- Applicant: Fem Suite, LLC
- Decided: May 18, 2010 after 217 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: 9 generations back to K931154 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961688: Microspan Hysteroscope, Imagyn Medical, Inc. (1996) Summary page 2.
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4, Gyrus Acmi, Inc. (2009) Summary page 2.

## Indications for use
The FernEye TWoTm Hysteroseope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: * Abnormal Uterine Bleeding * Infertility and Pregnancy Wastage * Evaluation of Abnormal Hysterosalpingogramn, * Intrauterine Foreign Body * Amenorrhea * Pelvic Pain

Source page: https://510kreport.com/device/K093218
Methodology: https://510kreport.com/methodology