# K222798: Rejoni Intrauterine Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rejoni, Inc.
- Decided: Dec 16, 2022 after 91 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: 5 generations back to K953034 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180300: Margolin HSG Cannula, Goldstein Sonohysterography Catheter, Cook Incorporated (2018) Summary page 4.
- (no number) Margolin HSG Cannula: named in the summary without a submission number

## Indications for use
The Rejoni Intrauterine Catheter 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 Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

Source page: https://510kreport.com/device/K222798
Methodology: https://510kreport.com/methodology