# K013437: SF SH Catheter, Model R65-945

- Pathway: 510(k) (Traditional)
- Applicant: A & A Medical, Inc.
- Decided: Nov 19, 2001 after 33 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ultra Catheter Set for Sonohysterography, from Lyco Enterprises, Inc.: named in the summary without a submission number

## Indications for use
THE SONOHYSTEROGRAPHIC CATHETER (5F) IS INDICATED & USED TO FILL THE UTERUS WITH STERILE SALINE TO FACILITATE THE ULTRASOUND EXAMINATION OF THE UTERUS

Source page: https://510kreport.com/device/K013437
Methodology: https://510kreport.com/methodology