# K123258: The Advance Catheter for HSG and Sis

- Pathway: 510(k) (Special)
- Applicant: Catheter Research, Inc.
- Decided: Jan 31, 2013 after 105 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). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032835: H/S Catheter Set, Catheter Research, Inc. (2003) Summary page 1.
- K083690: Femvue (TM) Catheter System, Femasys, Inc. (2009) Summary page 1.

## Most influential descendants
- K160217: uVue HSG/SHG Catheter (2016), 1 descendant of its own
- K181770: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (2019), 0 descendants of its own
- K180291: Cook Silicone Balloon HSG Catheter (2018), 0 descendants of its own

## Indications for use
The intended use of "The Advance Catheter for HSG and 515" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (515) into the female reproductive tract for examination of the uterus andWar fallopian tubes. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency. The Advance Catheter for HSG and 515 will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.

Source page: https://510kreport.com/device/K123258
Methodology: https://510kreport.com/methodology