# K180300: Margolin HSG Cannula, Goldstein Sonohysterography Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 26, 2018 after 266 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: 4 generations back to K953034 (1995). 4 ancestors in all.
1 later device descends 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)
- K083594: EZ HSG Catheter.Foamseal Catheter, Obg Products (2009) Summary page 4.

## Most influential descendants
- K222798: Rejoni Intrauterine Catheter (2022), 0 descendants of its own

## Indications for use
The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency. The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

Source page: https://510kreport.com/device/K180300
Methodology: https://510kreport.com/methodology