# K100662: Femvue Cornual Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Femasys, Inc.
- Decided: Apr 7, 2010 after 30 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K083690 (2009). 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)
- K083690: Femvue (TM) Catheter System, Femasys, Inc. (2009) Summary page 1.

## Indications for use
The FemVue TM Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.

Source page: https://510kreport.com/device/K100662
Methodology: https://510kreport.com/methodology