# K083594: EZ HSG Catheter.Foamseal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Obg Products
- Decided: Jul 21, 2009 after 228 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: 3 generations back to K953034 (1995). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013972: H/S Elliptosphere Catheter Set, Model 61-4005, Ackard Laboratories (2001) Summary page 2.

## Most influential descendants
- K180300: Margolin HSG Cannula, Goldstein Sonohysterography Catheter (2018), 1 descendant of its own
- K222798: Rejoni Intrauterine Catheter (2022), 0 descendants of its own

## Indications for use
Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG), Following are some Clinical Indications: 1. Infertility. 2. Menorrahagia. 3. Dysmenorrhea. 4. Suspected Endometrial Polyp. 5. Uterine Fibroid. 6. Amenorrhea due to Uterine Synechea (Asherman Syndrome). 7. Congenital Uterine Anomaly.

Source page: https://510kreport.com/device/K083594
Methodology: https://510kreport.com/methodology