# K040238: Softseal HSG Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Modern Medical Equipment Mfg., Ltd.
- Decided: Jun 22, 2004 after 148 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061679: Wallace Artificial Insemination Catheter (2006), 3 descendants of its own
- K131491: Kitazato Iui Catheter (2013), 1 descendant of its own
- K163318: Soules Intrauterine Insemination Catheter (2017), 0 descendants of its own
- K162667: Kitazato IUI Catheter (2017), 0 descendants of its own

## Indications for use
Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for the injection and retention of contrast fluid (or gas) into the uterus to enable the performance of sonohysterography. The device is not for intrafallopian procedure. The following clinical indications are some of the applications 1. Infertility 2. Menorrhagia 3. Dysmenorrhca Due to Uterine Synechia 4. Suspected Endometrial Polyp 5. Submucous Fibroid 6. Amenorrhea due to Uterine Synechia (Asherman Syndrome) 7. Congenital Uterine Abnormality

Source page: https://510kreport.com/device/K040238
Methodology: https://510kreport.com/methodology