# K221965: FemDx FalloView

- Pathway: 510(k) (Traditional)
- Applicant: Femdx Medsystems, Inc.
- Decided: Mar 17, 2023 after 255 days
- Product code: MKO (Falloposcope)
- 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: 1 generation back to K962587 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962587: Conceptus Fallopian Tube Catheteization with Microendoscopy System, Conceptus, Inc. (1997) Summary page 4.

## Indications for use
The FemDx FalloViewTM is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.

Source page: https://510kreport.com/device/K221965
Methodology: https://510kreport.com/methodology