# K041062: Intrauterine Venogram Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Oct 1, 2004 after 161 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: 1 generation back to K891290 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891290: Sholkoff Balloon Hysterosalpingography Catheter, Cook Ob/Gyn (1989) Summary page 1.
- (no number) Echotip Disposable Percutaneous Needle: named in the summary without a submission number

## Indications for use
The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion

Source page: https://510kreport.com/device/K041062
Methodology: https://510kreport.com/methodology